Ophthalmic Device Classification Codes

HQY Class 1

Sunglasses (Non-Prescription Including Photosensitive)

Clearances 646

Regulation 21 CFR 886.5850

View devices →

LPL Class 2

Lenses, Soft Contact, Daily Wear

Clearances 460

Regulation 21 CFR 886.5925

View devices →

HQC Class 2

Unit, Phacofragmentation

Clearances 309

Regulation 21 CFR 886.4670

View devices →

HQZ Class 1

Frame, Spectacle

Clearances 198

Regulation 21 CFR 886.5842

View devices →

HQF Class 2

Laser, Ophthalmic

Clearances 173

Regulation 21 CFR 886.4390

View devices →

HKI Class 2

Camera, Ophthalmic, Ac-Powered

Clearances 153

Regulation 21 CFR 886.1120

View devices →

HQE Class 2

Instrument, Vitreous Aspiration And Cutting, Ac-Powered

Clearances 148

Regulation 21 CFR 886.4150

View devices →

LPN Class 2

Accessories, Soft Lens Products

Clearances 119

Regulation 21 CFR 886.5928

View devices →

HQD Class 2

Lens, Contact (Other Material) - Daily

Clearances 117

Regulation 21 CFR 886.5916

View devices →

HJO Class 2

Biomicroscope, Slit-Lamp, Ac-Powered

Clearances 97

Regulation 21 CFR 886.1850

View devices →

HNO Class 1

Keratome, Ac-Powered

Clearances 83

Regulation 21 CFR 886.4370

View devices →

HLI Class 2

Ophthalmoscope, Ac-Powered

Clearances 81

Regulation 21 CFR 886.1570

View devices →

HMX Class 1

Cannula, Ophthalmic

Clearances 77

Regulation 21 CFR 886.4350

View devices →

LRX Class 2

Case, Contact Lens

Clearances 77

Regulation 21 CFR 886.5928

View devices →

OBO Class 2

Tomography, Optical Coherence

Clearances 63

Regulation 21 CFR 886.1570

View devices →

HKX Class 2

Tonometer, Ac-Powered

Clearances 57

Regulation 21 CFR 886.1930

View devices →

HQG Class 1

Lens, Spectacle, Non-Custom (Prescription)

Clearances 56

Regulation 21 CFR 886.5844

View devices →

MSS Class 1

Folders And Injectors, Intraocular Lens (Iol)

Clearances 55

Regulation 21 CFR 886.4300

View devices →

HNN Class 1

Knife, Ophthalmic

Clearances 54

Regulation 21 CFR 886.4350

View devices →

HOY Class 1

Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Clearances 54

Regulation 21 CFR 886.4750

View devices →

HKY Class 2

Tonometer, Manual

Clearances 51

Regulation 21 CFR 886.1930

View devices →

HOZ Class 2

Sponge, Ophthalmic

Clearances 47

Regulation 21 CFR 886.4790

View devices →

HLJ Class 2

Ophthalmoscope, Battery-Powered

Clearances 44

Regulation 21 CFR 886.1570

View devices →

HNR Class 1

Forceps, Ophthalmic

Clearances 44

Regulation 21 CFR 886.4350

View devices →

HPT Class 1

Perimeter, Automatic, Ac-Powered

Clearances 41

Regulation 21 CFR 886.1605

View devices →

KYG Class 1

Device, Irrigation, Ocular Surgery

Clearances 40

Regulation 21 CFR 886.4360

View devices →

HJK Class 2

Lens, Contact, Polymethylmethacrylate, Diagnostic

Clearances 39

Regulation 21 CFR 886.1385

View devices →

HPZ Class 2

Implant, Eye Sphere

Clearances 39

Regulation 21 CFR 886.3320

View devices →

KYB Class 1

Lens, Guide, Intraocular

Clearances 38

Regulation 21 CFR 886.4300

View devices →

OOE Class 2

Ophthalmic Femtosecond Laser

Clearances 38

Regulation 21 CFR 886.4390

View devices →

HKO Class 1

Refractometer, Ophthalmic

Clearances 35

Regulation 21 CFR 886.1760

View devices →

MRC Class 2

Products, Contact Lens Care, Rigid Gas Permeable

Clearances 33

Regulation 21 CFR 886.5918

View devices →

HOX Class 1

Chart, Visual Acuity

Clearances 32

Regulation 21 CFR 886.1150

View devices →

HQB Class 2

Photocoagulator And Accessories

Clearances 30

Regulation 21 CFR 886.4690

View devices →

HLQ Class 1

Keratoscope, Ac-Powered

Clearances 29

Regulation 21 CFR 886.1350

View devices →

HQP Class 2

Unit, Cautery, Thermal, Battery-Powered

Clearances 24

Regulation 21 CFR 886.4115

View devices →

KYF Class 2

Implant, Eye Valve

Clearances 24

Regulation 21 CFR 886.3920

View devices →

MVN Class 2

Lens, Contact, (Disposable)

Clearances 24

Regulation 21 CFR 886.5925

View devices →

LYL Class 2

Accessories, Solution, Ultrasonic Cleaners For Lenses

Clearances 22

Regulation 21 CFR 886.5928

View devices →

MXK Class 2

Device, Analysis, Anterior Segment

Clearances 22

Regulation 21 CFR 886.1850

View devices →

HNY Class 1

Cystotome

Clearances 20

Regulation 21 CFR 886.4350

View devices →

MOE Class 1

Collagen Corneal Shield

Clearances 19

Regulation 21 CFR 886.4750

View devices →

MYC Class 2

Ophthalmoscope, Laser, Scanning

Clearances 19

Regulation 21 CFR 886.1570

View devices →

HLX Class 2

Photostimulator, Ac-Powered

Clearances 18

Regulation 21 CFR 886.1630

View devices →

HKP Class 2

Instrument, Vitreous Aspiration And Cutting, Battery-Powered

Clearances 16

Regulation 21 CFR 886.4150

View devices →

HLM Class 1

Instrument, Measuring, Lens, Ac-Powered

Clearances 16

Regulation 21 CFR 886.1425

View devices →

HME Class 1

Chair, Ophthalmic, Ac-Powered

Clearances 16

Regulation 21 CFR 886.1140

View devices →

HQX Class 2

Implant, Orbital, Extra-Ocular

Clearances 16

Regulation 21 CFR 886.3340

View devices →

HMF Class 1

Stand, Instrument, Ac-Powered, Ophthalmic

Clearances 15

Regulation 21 CFR 886.1860

View devices →

HNF Class 1

Scissors, Ophthalmic

Clearances 15

Regulation 21 CFR 886.4350

View devices →

HPC Class 1

Set, Lens, Trial, Ophthalmic

Clearances 13

Regulation 21 CFR 886.1405

View devices →

LQJ Class 2

Lens, Surgical, Laser, Accesssory, Ophthalmic Laser

Clearances 13

Regulation 21 CFR 886.4390

View devices →

MML Class 2

Weights, Eyelid, External

Clearances 13

Regulation 21 CFR 886.5700

View devices →

HJM Class 2

Transilluminator, Ac-Powered

Clearances 12

Regulation 21 CFR 886.1945

View devices →

HMY Class 1

Keratome, Battery-Powered

Clearances 12

Regulation 21 CFR 886.4370

View devices →

HQO Class 2

Unit, Cautery, Thermal, Ac-Powered

Clearances 12

Regulation 21 CFR 886.4115

View devices →

HRH Class 1

Trephine, Manual, Ophthalmic

Clearances 12

Regulation 21 CFR 886.4350

View devices →

KYE Class 1

Inserter/Remover Contact Lens

Clearances 12

Regulation 21 CFR 886.5420

View devices →

ORZ Class 2

Eyelid Thermal Pulsation System

Clearances 12

Regulation 21 CFR 886.5200

View devices →

HLZ Class 2

Electrode, Corneal

Clearances 11

Regulation 21 CFR 886.1220

View devices →

HNC Class 1

Specula, Ophthalmic

Clearances 11

Regulation 21 CFR 886.4350

View devices →

HOI Class 1

Spectacle, Magnifying

Clearances 11

Regulation 21 CFR 886.5840

View devices →

HPS Class 2

Unit, Cryophthalmic

Clearances 11

Regulation 21 CFR 886.4170

View devices →

HQR Class 2

Apparatus, Cautery, Radiofrequency, Ac-Powered

Clearances 11

Regulation 21 CFR 886.4100

View devices →

HNL Class 1

Probe, Lachrymal

Clearances 10

Regulation 21 CFR 886.4350

View devices →

HNQ Class 1

Hook, Ophthalmic

Clearances 10

Regulation 21 CFR 886.4350

View devices →

HRN Class 2

Unit, Cryophthalmic, Ac-Powered

Clearances 10

Regulation 21 CFR 886.4170

View devices →

LXP Class 2

Plug, Scleral

Clearances 10

Regulation 21 CFR 886.4155

View devices →

HIT Class 1

Tester, Color Vision

Clearances 9

Regulation 21 CFR 886.1170

View devices →

HKS Class 1

Prism, Gonioscopic

Clearances 9

Regulation 21 CFR 886.1660

View devices →

HOS Class 1

Projector, Ophthalmic

Clearances 9

Regulation 21 CFR 886.1680

View devices →

HJG Class 1

System, Reading, Television, Closed-Circuit

Clearances 8

Regulation 21 CFR 886.5820

View devices →

HJI Class 1

Lens, Fundus, Hruby, Diagnostic

Clearances 8

Regulation 21 CFR 886.1395

View devices →

NQE Class 2

Microscope, Specular

Clearances 8

Regulation 21 CFR 886.1850

View devices →

HKM Class 1

Retinoscope, Battery-Powered

Clearances 7

Regulation 21 CFR 886.1780

View devices →

HLR Class 1

Keratoscope, Battery-Powered

Clearances 7

Regulation 21 CFR 886.1350

View devices →

HNH Class 1

Ring, Ophthalmic (Flieringa)

Clearances 7

Regulation 21 CFR 886.4350

View devices →

HOE Class 1

Caliper, Ophthalmic

Clearances 7

Regulation 21 CFR 886.4350

View devices →

HOQ Class 1

Grid, Amsler

Clearances 7

Regulation 21 CFR 886.1330

View devices →

HPG Class 1

Aid, Vision, Electronic, Battery-Powered

Clearances 7

Regulation 21 CFR 886.5900

View devices →

HPL Class 1

Device, Fixation, Ac-Powered, Ophthalmic

Clearances 7

Regulation 21 CFR 886.1290

View devices →

HQN Class 2

Conformer, Ophthalmic

Clearances 7

Regulation 21 CFR 886.3130

View devices →

HRJ Class 1

Table, Instrument, Powered, Ophthalmic

Clearances 7

Regulation 21 CFR 886.4855

View devices →

PIB Class 2

Diabetic Retinopathy Detection Device

Clearances 7

Regulation 21 CFR 886.1100

View devices →

FCT Class 2

Headlight, Fiberoptic Focusing

Clearances 6

Regulation 21 CFR 886.4335

View devices →

HKL Class 2

Retinoscope, Ac-Powered

Clearances 6

Regulation 21 CFR 886.1780

View devices →

HND Class 1

Spatula, Ophthalmic

Clearances 6

Regulation 21 CFR 886.4350

View devices →

HOO Class 1

Perimeter, Ac-Powered

Clearances 6

Regulation 21 CFR 886.1605

View devices →

HQH Class 1

Eye, Artificial, Non-Custom

Clearances 6

Regulation 21 CFR 886.3200

View devices →

HRG Class 1

Engine, Trephine, Accessories, Ac-Powered

Clearances 6

Regulation 21 CFR 886.4070

View devices →

LCC Class 2

Applicator, Ocular Pressure

Clearances 6

Regulation 21 CFR 886.4610

View devices →

LXS Class 2

Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

Clearances 6

Regulation 21 CFR 886.4392

View devices →

MUW Class 2

Lens, Contact (Orthokeratology)

Clearances 6

Regulation 21 CFR 886.5916

View devices →

HJA Class 1

Photokeratoscope

Clearances 5

Regulation 21 CFR 886.1350

View devices →

HJB Class 1

Instrument, Measuring, Corneal Radius

Clearances 5

Regulation 21 CFR 886.1450

View devices →

HMR Class 1

Marker, Ocular

Clearances 5

Regulation 21 CFR 886.4570

View devices →

HOG Class 1

Burr, Corneal, Battery-Powered

Clearances 5

Regulation 21 CFR 886.4070

View devices →

HPA Class 1

Frame, Trial, Ophthalmic

Clearances 5

Regulation 21 CFR 886.1415

View devices →

HPJ Class 2

Instrument, Visual Field, Laser

Clearances 5

Regulation 21 CFR 886.1360

View devices →

HPN Class 1

Magnet, Permanent

Clearances 5

Regulation 21 CFR 886.4445

View devices →

HPQ Class 2

Headlamp, Operating, Ac-Powered

Clearances 5

Regulation 21 CFR 886.4335

View devices →

HQJ Class 2

Implant, Absorbable, (Scleral Buckling Methods)

Clearances 5

Regulation 21 CFR 886.3300

View devices →

HQL Class 3

Intraocular Lens

Clearances 5

Regulation 21 CFR 886.3600

View devices →

MLP Class 2

Keratoprosthesis, Temporary Implant, Surgical Use

Clearances 5

Regulation 21 CFR 886.3400

View devices →

MMQ Class 1

Topographer, Corneal, Ac-Powered

Clearances 5

Regulation 21 CFR 886.1350

View devices →

MSR Class 2

Tubing, Replacement, Phacofragmentation Unit

Clearances 5

Regulation 21 CFR 886.4150

View devices →

NKX Class 2

Needle, Phacoemulsification, Reprocessed

Clearances 5

Regulation 21 CFR 886.4670

View devices →

OTZ Class 1

Graft Insertion Instrument For Endothelial Keratoplasty

Clearances 5

Regulation 21 CFR 886.4300

View devices →

FSR Class 2

Light, Headband, Surgical

Clearances 4

Regulation 21 CFR 886.4335

View devices →

HLL Class 2

Monitor, Eye Movement

Clearances 4

Regulation 21 CFR 886.1510

View devices →

HLT Class 2

Preamplifier, Ac-Powered, Ophthalmic

Clearances 4

Regulation 21 CFR 886.1640

View devices →

HMG Class 1

Stand, Instrument, Ophthalmic, Non-Powered

Clearances 4

Regulation 21 CFR 886.1860

View devices →

HPM Class 2

Locator, Metal, Electronic

Clearances 4

Regulation 21 CFR 886.4400

View devices →

HQA Class 2

Unit, Cryotherapy, Ophthalmic

Clearances 4

Regulation 21 CFR 886.4170

View devices →

HQM Class 2

Keratoprosthesis, Permanent Implant

Clearances 4

Regulation 21 CFR 886.3400

View devices →

HQT Class 2

Shell, Scleral

Clearances 4

Regulation 21 CFR 886.3800

View devices →

MLZ Class 2

Vitrectomy, Instrument Cutter

Clearances 4

Regulation 21 CFR 886.4150

View devices →

MQU Class 2

Ocular Peg

Clearances 4

Regulation 21 CFR 886.3320

View devices →

NCF Class 1

Aberrometer, Ophthalmic

Clearances 4

Regulation 21 CFR 886.1760

View devices →

OPT Class 2

Infrared Hematoma Detector

Clearances 4

Regulation 21 CFR 882.1935

View devices →

PUL Class 2

Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered

Clearances 4

Regulation 21 CFR 886.4100

View devices →

QQU Class 2

Digital Therapy Device For Amblyopia

Clearances 4

Regulation 21 CFR 886.5500

View devices →

HIW Class 1

Anomaloscope

Clearances 3

Regulation 21 CFR 886.1070

View devices →

HJH Class 1

Loupe, Binocular, Low Power

Clearances 3

Regulation 21 CFR 886.5120

View devices →

HJN Class 1

Transilluminator, Battery-Powered

Clearances 3

Regulation 21 CFR 886.1945

View devices →

HKN Class 1

Refractor, Manual, Non-Powered, Including Phoropter

Clearances 3

Regulation 21 CFR 886.1770

View devices →

HLF Class 1

Device, Measuring, Lens Radius, Ophthalmic

Clearances 3

Regulation 21 CFR 886.1430

View devices →

HLG Class 1

Pupillometer, Ac-Powered

Clearances 3

Regulation 21 CFR 886.1700

View devices →

HLP Class 1

Target, Fusion And Stereoscopic

Clearances 3

Regulation 21 CFR 886.1880

View devices →

HLW Class 2

Preamplifier, Battery-Powered, Ophthalmic

Clearances 3

Regulation 21 CFR 886.1640

View devices →

HNJ Class 1

Punch, Corneo-Scleral

Clearances 3

Regulation 21 CFR 886.4350

View devices →

HNW Class 1

Dilator, Lachrymal

Clearances 3

Regulation 21 CFR 886.4350

View devices →

HOB Class 1

Clamp, Muscle, Ophthalmic

Clearances 3

Regulation 21 CFR 886.4350

View devices →

HOD Class 1

Clamp, Eyelid, Ophthalmic

Clearances 3

Regulation 21 CFR 886.4350

View devices →

HOH Class 1

Spectacle, Operating (Loupe), Ophthalmic

Clearances 3

Regulation 21 CFR 886.4770

View devices →

HOJ Class 1

Screen, Tangent, Target

Clearances 3

Regulation 21 CFR 886.1810

View devices →

HPO Class 2

Magnet, Ac-Powered

Clearances 3

Regulation 21 CFR 886.4440

View devices →

HQQ Class 2

Apparatus, Cautery, Radiofrequency, Battery-Powered

Clearances 3

Regulation 21 CFR 886.4100

View devices →

HQW Class 2

Clip, Tantalum, Ophthalmic

Clearances 3

Regulation 21 CFR 886.3100

View devices →

KYD Class 1

Strip, Schirmer

Clearances 3

Regulation 21 CFR 886.1800

View devices →

NCE Class 1

Injector, Capsular Tension Ring

Clearances 3

Regulation 21 CFR 886.4300

View devices →

NCR Class 2

Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered

Clearances 3

Regulation 21 CFR 886.4100

View devices →

NPB Class 2

System, Monitoring, For Progress Of Labor

Clearances 3

Regulation 21 CFR 884.2800

View devices →

QER Class 2

Camera, Ophthalmic, Slit-Scanning

Clearances 3

Regulation 21 CFR 886.1120

View devices →

FTZ Class 1

Locator, Magnetic

Clearances 2

Regulation 21 CFR 886.4445

View devices →

HIX Class 1

Maxwell Spot, Ac-Powered

Clearances 2

Regulation 21 CFR 886.1435

View devices →

HJC Class 1

Esthesiometer, Ocular

Clearances 2

Regulation 21 CFR 886.1040

View devices →

HJT Class 1

Haploscope

Clearances 2

Regulation 21 CFR 886.1340

View devices →

HKK Class 1

Telescope, Spectacle, Low-Vision

Clearances 2

Regulation 21 CFR 886.5870

View devices →

HKW Class 1

Prism, Bar, Ophthalmic

Clearances 2

Regulation 21 CFR 886.1650

View devices →

HLH Class 1

Pupillometer, Manual

Clearances 2

Regulation 21 CFR 886.1700

View devices →

HLN Class 1

Gauge, Lens, Ophthalmic

Clearances 2

Regulation 21 CFR 886.1420

View devices →

HMH Class 1

Rack, Skiascopic

Clearances 2

Regulation 21 CFR 886.1750

View devices →

HMJ Class 1

Screen, Tangent, Projection, Battery-Powered

Clearances 2

Regulation 21 CFR 886.1810

View devices →

HMM Class 1

Distometer

Clearances 2

Regulation 21 CFR 886.1190

View devices →

HNA Class 1

Spud, Ophthalmic

Clearances 2

Regulation 21 CFR 886.4350

View devices →

HNI Class 1

Retractor, Ophthalmic

Clearances 2

Regulation 21 CFR 886.4350

View devices →

HNM Class 1

Needle, Ophthalmic Suturing

Clearances 2

Regulation 21 CFR 886.4350

View devices →

HNX Class 1

Depressor, Orbital

Clearances 2

Regulation 21 CFR 886.4350

View devices →

HNZ Class 1

Curette, Ophthalmic

Clearances 2

Regulation 21 CFR 886.4350

View devices →

HOC Class 1

Clip, Iris Retractor

Clearances 2

Regulation 21 CFR 886.4350

View devices →

HOT Class 1

Aid, Vision Image Intensification

Clearances 2

Regulation 21 CFR 886.5910

View devices →

HRK Class 1

Table, Instrument, Manual, Ophthalmic

Clearances 2

Regulation 21 CFR 886.4855

View devices →

MSG Class 2

Ophthalmoscopes, Replacement Batteries, Hand-Held

Clearances 2

Regulation 21 CFR 886.1570

View devices →

MTZ Class 2

Wrap, Implant, Orbital

Clearances 2

Regulation 21 CFR 886.3320

View devices →

NFM Class 2

Expander, Tissue, Orbital

Clearances 2

Regulation 21 CFR 886.3320

View devices →

NJH Class 1

Lens, Spectacle (Prescription), For Reading Discomfort

Clearances 2

Regulation 21 CFR 886.5844

View devices →

NXM Class 2

Prosthesis, Eyelid Spacer/Graft, Biologic

Clearances 2

Regulation 21 CFR 886.3130

View devices →

SCW Class 1

Digital Prismatic Correction

Clearances 2

Regulation 21 CFR 886.1655

View devices →

HJD Class 1

Illuminator, Color Vision Plate

Clearances 1

Regulation 21 CFR 886.1160

View devices →

HJF Class 1

Magnifier, Hand-Held, Low-Vision

Clearances 1

Regulation 21 CFR 886.5540

View devices →

HJL Class 1

Lens, Condensing, Diagnostic

Clearances 1

Regulation 21 CFR 886.1380

View devices →

HJQ Class 1

Stereoscope, Ac-Powered

Clearances 1

Regulation 21 CFR 886.1870

View devices →

HJX Class 1

Reader, Prism, Ophthalmic

Clearances 1

Regulation 21 CFR 886.5810

View devices →

HJY Class 1

Reader, Bar, Ophthalmic

Clearances 1

Regulation 21 CFR 886.5800

View devices →

HKC Class 1

Spectacle Microscope, Low-Vision

Clearances 1

Regulation 21 CFR 886.5540

View devices →

HLS Class 1

Exophthalmometer

Clearances 1

Regulation 21 CFR 886.1270

View devices →

HMC Class 2

Monitor, Eye Movement, Diagnostic

Clearances 1

Regulation 21 CFR 886.1510

View devices →

HMD Class 1

Chair, Ophthalmic, Manual

Clearances 1

Regulation 21 CFR 886.1140

View devices →

HMS Class 1

Drum, Eye Knife Test

Clearances 1

Regulation 21 CFR 886.4230

View devices →

HOF Class 1

Burr, Corneal, Manual

Clearances 1

Regulation 21 CFR 886.4350

View devices →

HOK Class 1

Screen, Tangent, Projection, Ac-Powered

Clearances 1

Regulation 21 CFR 886.1810

View devices →

HOM Class 1

Screen, Tangent, Ac-Powered (Campimeter)

Clearances 1

Regulation 21 CFR 886.1810

View devices →

HOR Class 1

Simulatan (Including Crossed Cylinder)

Clearances 1

Regulation 21 CFR 886.1840

View devices →

HOW Class 1

Drum, Opticokinetic

Clearances 1

Regulation 21 CFR 886.1200

View devices →

HPE Class 1

Aid, Vision, Optical, Battery-Powered

Clearances 1

Regulation 21 CFR 886.5915

View devices →

HPF Class 1

Aid, Vision, Electronic, Ac-Powered

Clearances 1

Regulation 21 CFR 886.5900

View devices →

HPY Class 1

Unit, Electrolysis, Battery-Powered, Ophthalmic

Clearances 1

Regulation 21 CFR 886.4250

View devices →

HQS Class 1

Burr, Corneal, Ac-Powered

Clearances 1

Regulation 21 CFR 886.4070

View devices →

HRC Class 2

Sterilizer, Soft-Lens, Thermal, Battery-Powered

Clearances 1

Regulation 21 CFR 886.5928

View devices →

HRD Class 2

Sterilizer, Soft-Lens, Thermal, Ac-Powered

Clearances 1

Regulation 21 CFR 886.5928

View devices →

LWL Class 3

Fluid, Intraocular

Clearances 1

Regulation 21 CFR 886.4275

View devices →

MMF Class 2

Photorefractor

Clearances 1

Regulation 21 CFR 886.1120

View devices →

MUS Class 2

Fluidic, Phacoemulsification/Phacofragmentation

Clearances 1

Regulation 21 CFR 886.4670

View devices →

MYD Class 1

Keratome, Water Jet

Clearances 1

Regulation 21 CFR 886.4370

View devices →

MZD Class 2

System, In-Office Tinting, Contact Lenses

Clearances 1

Regulation 21 CFR 886.5925

View devices →

NAI Class 1

Lens, Prescription, Color Deficiency

Clearances 1

Regulation 21 CFR 886.5844

View devices →

NCB Class 2

Weights, Eyelid, Implantable

Clearances 1

Regulation 21 CFR 886.5700

View devices →

NCK Class 1

Button, Iris, Eye, Artificial

Clearances 1

Regulation 21 CFR 886.3200

View devices →

NCZ Class 2

Lens, Contact, For Color Vision Deficiency

Clearances 1

Regulation 21 CFR 886.5925

View devices →

NFD Class 1

Selector, Color, Spectacle, Lens, Tint

Clearances 1

Regulation 21 CFR 886.1160

View devices →

NGY Class 1

Cannula, Trocar, Ophthalmic

Clearances 1

Regulation 21 CFR 886.4350

View devices →

NIC Class 2

Lens, Contact, For Reading Discomfort

Clearances 1

Regulation 21 CFR 886.5925

View devices →

NJJ Class 2

Tonometer, Analyzer, Ocular Blood Flow

Clearances 1

Regulation 21 CFR 886.1930

View devices →

NQB Class 2

Conformer, Ophthalmic, Biological Tissue

Clearances 1

Regulation 21 CFR 886.3130

View devices →

NXR Class 1

Fixation, Vision Training, Binocular

Clearances 1

Regulation 21 CFR 886.1290

View devices →

NYK Class 2

Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)

Clearances 1

Regulation 21 CFR 886.1385

View devices →

OUM Class 1

Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation

Clearances 1

Regulation 21 CFR 886.1050

View devices →

QBR Class 2

Intranasal Electrostimulation Device For Dry Eye Symptoms

Clearances 1

Regulation 21 CFR 886.5310

View devices →

QKV Class 2

Electromechanical Tear Stimulator

Clearances 1

Regulation 21 CFR 886.5305

View devices →

QQJ Class 2

Applicator, Negative Pressure, External, Ocular

Clearances 1

Regulation 21 CFR 886.5000

View devices →

QTO Class 1

Digital Visual Acuity Test

Clearances 1

Regulation 21 CFR 886.1150

View devices →

QTW Class 1

Digital Amsler Grid

Clearances 1

Regulation 21 CFR 886.1330

View devices →

QWU Class 2

Prosthesis, Eyelid Spacer/Graft, Polymer

Clearances 1

Regulation 21 CFR 886.3130

View devices →

SBI Class 1

Manual Refractor, 3d Display

Clearances 1

Regulation 21 CFR 886.1770

View devices →

SBN Class 1

Digital Therapy Device For Convergence Insufficiency

Clearances 1

Regulation 21 CFR 886.1290

View devices →

HIY Class 1

Brush, Haidinger, (Including Macular Integrity)

Clearances 0

Regulation 21 CFR 886.1090

View devices →

HJJ Class 1

Lens, Fresnel, Flexible, Diagnostic

Clearances 0

Regulation 21 CFR 886.1390

View devices →

HJR Class 1

Stereoscope, Battery-Powered

Clearances 0

Regulation 21 CFR 886.1870

View devices →

HJS Class 1

Test, Spectacle Dissociation, Ac-Powered (Lancaster)

Clearances 0

Regulation 21 CFR 886.1910

View devices →

HJW Class 1

Adaptometer (Biophotometer)

Clearances 0

Regulation 21 CFR 886.1050

View devices →

HJZ Class 1

Crutch, Ptosis

Clearances 0

Regulation 21 CFR 886.5600

View devices →

HKB Class 1

Telescope, Hand-Held, Low-Vision

Clearances 0

Regulation 21 CFR 886.5870

View devices →

HKD Class 1

Tape, Nystagmus

Clearances 0

Regulation 21 CFR 886.1905

View devices →

HKF Class 1

Mirror, Headband, Ophthalmic

Clearances 0

Regulation 21 CFR 886.1500

View devices →

HKG Class 1

Fornixscope

Clearances 0

Regulation 21 CFR 886.1320

View devices →

HKQ Class 1

Prism, Rotary, Ophthalmic

Clearances 0

Regulation 21 CFR 886.1665

View devices →

HKR Class 1

Lens, Maddox

Clearances 0

Regulation 21 CFR 886.1400

View devices →

HKT Class 1

Prism, Fresnel, Ophthalmic

Clearances 0

Regulation 21 CFR 886.1655

View devices →

HKZ Class 1

Sterilizer, Tonometer

Clearances 0

Regulation 21 CFR 886.1940

View devices →

HLA Class 2

Calibrator, Tonometer

Clearances 0

Regulation 21 CFR 886.1930

View devices →

HLC Class 1

Instrument, Measuring, Stereopsis

Clearances 0

Regulation 21 CFR 886.1460

View devices →

HLD Class 1

Engine, Trephine, Accessories, Gas-Powered

Clearances 0

Regulation 21 CFR 886.4070

View devices →

HLE Class 1

Ruler, Nearpoint (Punctometer)

Clearances 0

Regulation 21 CFR 886.1790

View devices →

HLK Class 1

Screen, Tangent, Target, Battery-Powered

Clearances 0

Regulation 21 CFR 886.1810

View devices →

HLO Class 1

Test, Spectacle Dissociation, Battery-Powered (Lancaster)

Clearances 0

Regulation 21 CFR 886.1910

View devices →

HMK Class 2

Euthyscope, Ac-Powered

Clearances 0

Regulation 21 CFR 886.1250

View devices →

HML Class 1

Euthyscope, Battery-Powered

Clearances 0

Regulation 21 CFR 886.1250

View devices →

HMQ Class 1

Marker, Sclera

Clearances 0

Regulation 21 CFR 886.4570

View devices →

HMZ Class 1

Trabeculotome

Clearances 0

Regulation 21 CFR 886.4350

View devices →

HNB Class 1

Spoon, Ophthalmic

Clearances 0

Regulation 21 CFR 886.4350

View devices →

HNE Class 1

Snare, Enucleating

Clearances 0

Regulation 21 CFR 886.4350

View devices →

HNG Class 1

Rongeur, Lachrymal Sac

Clearances 0

Regulation 21 CFR 886.4350

View devices →

HNK Class 1

Probe, Trabeculotomy

Clearances 0

Regulation 21 CFR 886.4350

View devices →

HNP Class 1

Introducer, Sphere

Clearances 0

Regulation 21 CFR 886.4350

View devices →

HNS Class 1

Expressor

Clearances 0

Regulation 21 CFR 886.4350

View devices →

HNT Class 1

Erisophake

Clearances 0

Regulation 21 CFR 886.4350

View devices →

HOA Class 1

Compressor, Orbital

Clearances 0

Regulation 21 CFR 886.4350

View devices →

HOL Class 1

Screen, Tangent, Felt (Campimeter)

Clearances 0

Regulation 21 CFR 886.1810

View devices →

HON Class 1

Perimeter, Manual

Clearances 0

Regulation 21 CFR 886.1605

View devices →

HOP Class 1

Campimeter, Stereo, Battery-Powered

Clearances 0

Regulation 21 CFR 886.1810

View devices →

HPB Class 1

Clip, Lens, Trial, Ophthalmic

Clearances 0

Regulation 21 CFR 886.1410

View devices →

HPD Class 1

Lens, Bagolini

Clearances 0

Regulation 21 CFR 886.1375

View devices →

HPI Class 1

Aid, Vision, Optical, Ac-Powered

Clearances 0

Regulation 21 CFR 886.5915

View devices →

HPK Class 2

Tonograph

Clearances 0

Regulation 21 CFR 886.1930

View devices →

HPP Class 1

Headlamp, Operating, Battery-Operated

Clearances 0

Regulation 21 CFR 886.4335

View devices →

HPW Class 2

Probe And Counter, Isotope, For Phosphorus 32

Clearances 0

Regulation 21 CFR 886.1670

View devices →

HRE Class 1

Cabinet, Instrument, Ac-Powered, Ophthalmic

Clearances 0

Regulation 21 CFR 886.1860

View devices →

HRF Class 1

Engine, Trephine, Accessories, Battery-Powered

Clearances 0

Regulation 21 CFR 886.4070

View devices →

HRI Class 1

Pupillograph

Clearances 0

Regulation 21 CFR 886.1690

View devices →

HRL Class 2

Unit, Beta, Radiation, Ophthalmic

Clearances 0

Regulation 21 CFR 886.5100

View devices →

HRO Class 2

Unit, Electrolysis, Ac-Powered, Ophthalmic

Clearances 0

Regulation 21 CFR 886.4250

View devices →

HRP Class 1

Pen, Marking, Surgical

Clearances 0

Regulation 21 CFR 886.4570

View devices →

LPM Class 3

Lenses, Soft Contact, Extended Wear

Clearances 0

Regulation 21 CFR 886.5925

View devices →

LPO Class 3

Gases Used Within Eye To Place Pressure On Detached Retina

Clearances 0

Regulation 21 CFR 886.4270

View devices →

LZP Class 3

Aid, Surgical, Viscoelastic

Clearances 0

Regulation 21 CFR 886.4275

View devices →

LZR Class 2

Ultrasound, Cyclodestructive

Clearances 0

Regulation 21 CFR 886.5350

View devices →

MFK Class 3

Lens, Multifocal Intraocular

Clearances 0

Regulation 21 CFR 886.3600

View devices →

MJP Class 3

Lens, Intraocular, Toric Optics

Clearances 0

Regulation 21 CFR 886.3600

View devices →

MMC Class 2

Dilator, Expansive Iris (Accessory)

Clearances 0

Regulation 21 CFR 886.4150

View devices →

MWL Class 3

Lens, Contact (Rigid Gas Permeable), Extended Wear

Clearances 0

Regulation 21 CFR 886.5916

View devices →

MXO Class 2

Laser, System, Phacolysis

Clearances 0

Regulation 21 CFR 886.4670

View devices →

MXY Class 1

Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal

Clearances 0

Regulation 21 CFR 886.4350

View devices →

NAA Class 3

Lens, Intraocular, Accommodative

Clearances 0

Regulation 21 CFR 886.3600

View devices →

NIZ Class 3

Lens, Iris Reconstruction

Clearances 0

Regulation 21 CFR 886.3600

View devices →

NJG Class 2

Flasher, Afterimage, Ophthalmic

Clearances 0

Regulation 21 CFR 886.1300

View devices →

NKY Class 1

Blade, Keratome, Reprocessed

Clearances 0

Regulation 21 CFR 886.4370

View devices →

NLA Class 1

Knife, Ophthalmic, Reprocessed

Clearances 0

Regulation 21 CFR 886.4350

View devices →

NOG Class 1

Topographer, Corneal, Battery Powered

Clearances 0

Regulation 21 CFR 886.1350

View devices →

NOH Class 1

Photokeratoscope, Battery Powered

Clearances 0

Regulation 21 CFR 886.1350

View devices →

NOI Class 1

Stand, Instrument, Ophthalmic, Battery Powered

Clearances 0

Regulation 21 CFR 886.1860

View devices →

NUU Class 3

Lens, Contact, Orthokeratology, Overnight

Clearances 0

Regulation 21 CFR 886.5916

View devices →

NVB Class 3

Intraocular, Pressure Measuring Device

Clearances 0

Regulation 21 CFR 886.4280

View devices →

OHW Class 1

Burr, Corneal, Battery Powered, Rust Ring Removal

Clearances 0

Regulation 21 CFR 886.4070

View devices →

OHX Class 1

Burr, Corneal, Ac-Powered, Rust Ring Removal

Clearances 0

Regulation 21 CFR 886.4070

View devices →

OJK Class 2

Eye Tray

Clearances 0

Regulation 21 CFR 886.4790

View devices →

PIC Class 2

Oral Electronic Vision Aid

Clearances 0

Regulation 21 CFR 886.5905

View devices →

PJZ Class 2

Camera, Ophthalmic, General-Use

Clearances 0

Regulation 21 CFR 886.1120

View devices →

PLX Class 1

Tear Duct Occluder

Clearances 0

Regulation 21 CFR 886.5838

View devices →

PLZ Class 2

Ocular Pattern Recorder

Clearances 0

Regulation 21 CFR 886.1925

View devices →

PMW Class 2

Strabismus Detection Device

Clearances 0

Regulation 21 CFR 886.1342

View devices →

POE Class 3

Extended Depth Of Focus Intraocular Lens

Clearances 0

Regulation 21 CFR 886.3600

View devices →

PQJ Class 2

Intranasal Electrostimulation Device

Clearances 0

Regulation 21 CFR 886.5300

View devices →

PUE Class 2

Biomicroscope, Slit-Lamp, Ac-Powered, Exempt

Clearances 0

Regulation 21 CFR 886.1850

View devices →

PUF Class 2

Ocular Peg, Exempt

Clearances 0

Regulation 21 CFR 886.3320

View devices →

PZG Class 1

Surgical Eye Tray

Clearances 0

Regulation 21 CFR 886.4350

View devices →

PZK Class 3

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

Clearances 0

Regulation 21 CFR 886.3600

View devices →

QCB Class 3

Phakic Toric Intraocular Lens

Clearances 0

Regulation 21 CFR 886.3600

View devices →

QCW Class 2

Corneal Storage Media With Preservatives Including Anti-Fungal

Clearances 0

Regulation 21 CFR 886.4320

View devices →

QDV Class 1

Iol Tray

Clearances 0

Regulation 21 CFR 886.4350

View devices →

QDW Class 2

Phaco Kit

Clearances 0

Regulation 21 CFR 886.4670

View devices →

QDY Class 2

Vitrectomy Kit

Clearances 0

Regulation 21 CFR 886.4150

View devices →

QGJ Class 1

Corneal Inlay Inserter Handle

Clearances 0

Regulation 21 CFR 886.4355

View devices →

QIU Class 2

Intense Pulsed Light Device For Managing Dry Eye

Clearances 0

Regulation 21 CFR 886.5201

View devices →

QMM Class 2

Hydrophilic Re-Coating Solution

Clearances 0

Regulation 21 CFR 886.5919

View devices →

QQQ Class 1

Guide And Positioner, Ophthalmic Drug Delivery Device

Clearances 0

Regulation 21 CFR 886.4300

View devices →

QUR Class 2

Prescription Spectacle Lenses To Reduce The Progression Of Myopia

Clearances 0

Regulation 21 CFR 886.5845

View devices →

QZP Class 2

Camera, Ophthalmic, Non-Prescription

Clearances 0

Regulation 21 CFR 886.1120

View devices →

SAX Class 2

Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device

Clearances 0

Regulation 21 CFR 886.1600

View devices →

SDE Class 2

Light Based Device For Dry Age-Related Macular Degeneration

Clearances 0

Regulation 21 CFR 886.5520

View devices →