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Laser, Ophthalmic

FDA product code HQF · 173 cleared devices

Class 2 Ophthalmic

Regulation: 21 CFR 886.4390
Review panel: OP
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1978-12-28 – 2026-04-07

HQF 1993-11-22

NIDEK MODEL AC-2300

Applicant Nidek, Inc.

K number K932836

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HQF 1993-11-12

JR -- OPHTHALMIC ARGON LASER

Applicant Carson Laserworks

K number K932296

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HQF 1993-08-17

HGM ASPIRATING ENDOOCULAR(TM) PROBE

Applicant Hgm, Inc.

K number K925663

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HQF 1993-07-22

LASER AND EMPHASIS SCLEROSTOMY TIP

Applicant Summit Technology, Inc.

K number K926470

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HQF 1991-05-28

URAM OPHTHALMIC LASER ENDOSCOPE

Applicant Martin S. Knopf Assoc., Inc.

K number K910532

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HQF 1991-05-24

ND:YAG LASER SYSTEMS (VARIOUS MODELS)

Applicant Heraeus Lasersonics, Inc.

K number K910805

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HQF 1991-04-25

COMPAC(TM) DIODE LASERS

Applicant Hgm Medical Laser Systems, Inc.

K number K904699

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HQF 1991-03-05

CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND

Applicant Douglas James Donaldson Compliance Services

K number K905453

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HQF 1991-03-04

CANDELA DIODE TRABECULOPLASTY LASER DTL

Applicant Candela Laser Corp.

K number K910612

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HQF 1991-02-11

CENTAURI

Applicant Pfizer Laser Systems

K number K905141

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HQF 1990-12-18

TOPCON EC-200 ENDO-PHOTOCOAGULATOR LASER

Applicant Top Con

K number K903421

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HQF 1990-10-19

CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR

Applicant Douglas James Donaldson Compliance Services

K number K904366

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HQF 1990-03-27

LASAG MICRORUPTER 2 ND:YAG LASER TRABECULOPLASTY

Applicant Lasag AG

K number K900199

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HQF 1989-10-31

MICROLASE BY LASER TRABECULOPLASTY

Applicant Keeler Instruments, Inc.

K number K895213

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HQF 1989-10-16

MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR

Applicant Nidek, Inc.

K number K895196

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HQF 1989-09-21

LASERMED* GOGGLES AND SPECTACLES

Applicant Glendale Protective Technologies, Inc.

K number K894835

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HQF 1989-08-07

NIDEK MODEL AKC-8000

Applicant Nidek, Inc.

K number K894273

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HQF 1989-08-02

CANDELA UPC LASER PHOTOCOAGULATOR

Applicant Candela Laser Corp.

K number K893630

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HQF 1989-06-15

COHERENT MARIE ARGON PHOTOCOAGULATOR

Applicant Coherent Medical Group

K number K893709

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HQF 1989-03-24

INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM

Applicant Biophysic Medical, Inc.

K number K890509

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HQF 1989-03-15

MICROLASE 8 0 0 (OPHTHALMIC LASER)

Applicant Keeler Instruments, Inc.

K number K890086

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HQF 1989-01-10

LASAG MICRORUPTOR 2 ND:YAG OPHTH. LASER SYSTEM

Applicant Chiron Vision Corp.

K number K885164

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HQF 1988-09-30

SLT CL60 CONTACT LASER SYSTEM, CUTTING & COAGULA.

Applicant Surgical Laser Technologies, Inc.

K number K882908

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HQF 1988-09-15

NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)

Applicant Nidek, Inc.

K number K883213

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HQF 1988-08-30

FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER

Applicant Biophysic Medical, Inc.

K number K881494

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HQF 1988-08-02

RESUBMITTED DIODE LASER COAGULATOR

Applicant CooperVision, Inc.

K number K882372

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HQF 1988-06-06

SLT CONTACT LASER SYSTEM OCULOPLASTICS

Applicant Surgical Laser Technologies, Inc.

K number K881134

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HQF 1988-04-13

PRISMA DISPOSABLE ENDO-OCULAR PROBE

Applicant Advanced Surgical Products, Inc.

K number K875000

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HQF 1988-01-06

ZEISS VISULAS ARGON LASER

Applicant Carl Zeiss, Inc.

K number K874609

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HQF 1987-10-29

OPHTHALAS DYE OPHTHALMIC LASER

Applicant Biophysic Medical, Inc.

K number K873460

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HQF 1987-10-15

NIDEK ADC-8000 LASER SYSTEM

Applicant Nidek, Inc.

K number K872846

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HQF 1987-05-22

MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC

Applicant Directed Energy, Inc.

K number K870839

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HQF 1986-11-13

ORION 3001, LASER PHOTOCOAGULATOR

Applicant G. Rodenstock Instrumente GmbH

K number K864063

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HQF 1986-10-31

MIRALITE

Applicant Mira, Inc.

K number K863246

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HQF 1986-10-10

ENDOPHOTOCOAGULATION PROBE

Applicant Mira, Inc.

K number K863591

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HQF 1986-10-07

LDS - LASER DELIVERY SYSTEM

Applicant Coherent Medical Group

K number K862568

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HQF 1986-09-24

MODEL 1000 OPHTHALMIC LASER SYSTEM

Applicant CooperVision, Inc.

K number K862987

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HQF 1986-03-21

FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE)

Applicant Hgm, Inc.

K number K860358

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HQF 1986-02-04

MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS

Applicant CooperVision, Inc.

K number K854949

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HQF 1985-11-12

OPHALMIC LASER PHOTOCOAGULATOR

Applicant Mira, Inc.

K number K854288

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HQF 1985-11-12

OPHTHALMIC LASER PHOTOCOAGULATOR

Applicant Mira, Inc.

K number K853890

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HQF 1985-09-24

HESSBURG GLIDE UNTRAOCULAR LENS GUIDES

Applicant Visitec Co.

K number K852529

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HQF 1985-08-01

MDS 83 OPHTHALMIC DYE LASER SYSTEM

Applicant Meditec, Inc.

K number K852234

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HQF 1985-07-25

HCG, INC. MEDICAL LASER ENDOCOAGULATOR MODEL P.C.

Applicant Hcg, Inc.

K number K852464

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HQF 1985-06-05

SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR

Applicant Coherent Medical Group

K number K844357

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HQF 1985-04-23

HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K

Applicant Hgm, Inc.

K number K850572

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HQF 1985-01-03

MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE

Applicant Cooper Lasersonics, Inc.

K number K844668

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HQF 1985-01-03

SYSTEM 920 PHOTOCOAGULATOR TO INCLUDE SCHIRMERSCOP

Applicant Coherent Medical Group

K number K844358

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HQF 1984-11-06

ARGON LASER PHOTOCOAGULATOR SYS

Applicant American Medical Optics

K number K843965

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HQF 1984-08-15

AMERI. MEDICAL OPTICS ARGON LASER PHOTO

Applicant American Medical Optics

K number K842251

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HQF 1984-08-15

AMER. MEDICAL OPTICS ARGON/KRYPTON LASE

Applicant American Medical Optics

K number K842250

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HQF 1984-06-26

MODEL 4000 MD-YAG LASER FOR MALIGNANT

Applicant Cooper Lasersonics, Inc.

K number K842412

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HQF 1984-06-19

AMER. MED. OPTICS ARGON LASER PHOTO

Applicant American Medical Optics

K number K841855

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HQF 1984-06-07

AMER. MED. OPTICS ARGON/KRYPTON LASER

Applicant American Medical Optics

K number K841856

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HQF 1984-05-09

FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE

Applicant Hgm, Inc.

K number K840590

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HQF 1984-04-25

MONITOR CO2 LASER SURGICAL SYSTEM

Applicant Cooper Lasersonics, Inc.

K number K840145

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HQF 1984-04-05

LASER LENS-VARIOUS MODELS

Applicant Meditec of America

K number K834610

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HQF 1984-04-02

MEDICAL LASER ENDOCOAGULATOR 5K

Applicant Hgm, Inc.

K number K840854

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HQF 1984-03-16

ARGON/KRYPTON ION LASER PHOTOCOAGULA

Applicant Nidek, Inc.

K number K834305

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HQF 1984-02-04

RELIANCE OPHTHALMIC SLIT LAMP R-083

Applicant F. & F. Koenigkramer

K number K834060

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HQF 1984-02-04

OCULASE 514 OPHTHALMIC ARGON LASER

Applicant Lasermed Corp.

K number K833532

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HQF 1984-01-30

LASER PHOTOCOAGULATOR 1520-A & K

Applicant Britt Corp., Inc.

K number K833533

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HQF 1984-01-30

OPHTHALMIC ARGON LASER #700A

Applicant Laser Industries , Ltd.

K number K832316

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HQF 1984-01-30

MODEL 150K LASER COAGULATOR

Applicant Lasertek OY

K number K832089

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HQF 1983-12-30

LASER PROTECTIVE EYESHIELD

Applicant Stefanovsky & Assoc.

K number K833232

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HQF 1983-12-03

DERMATOLOGY HANDPIECE-OPHTH LASER

Applicant Synemed, Inc.

K number K833274

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HQF 1982-01-22

BRITT KRYPTON LASERS 150K & 152K

Applicant Britt Corp., Inc.

K number K813492

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HQF 1981-11-16

MODEL 900S INTRAOCULAR PROBE

Applicant Lumenis, Inc.

K number K812219

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HQF 1980-07-28

MODEL 900K PHOTOCOAGULATOR

Applicant Coherent Medical Division

K number K801336

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HQF 1979-10-11

MEDITEC (RODENSTOCK) LASER PHOTOCOAGUL

Applicant Coburn Optical Ind., Inc.

K number K791659

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HQF 1979-02-08

COAGULATOR, MODEL 40 AARGON

Applicant Lasertek OY

K number K782106

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HQF 1979-02-08

LASER COAGULATOR, MODEL 41AK

Applicant Lasertek OY

K number K781965

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HQF 1978-12-28

LASER, PHOTOCOAGULATION

Applicant Cavitron Corp.

K number K782065

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