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Tonometer, Ac-Powered

FDA product code HKX · 57 cleared devices

Class 2 Ophthalmic

Regulation: 21 CFR 886.1930
Review panel: OP
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1980-08-04 – 2025-11-07

HKX 2025-11-07

AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA

Applicant Topcon Corporation

K number K253039

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HKX 2023-11-08

VS Tabletop Tonometer

Applicant Medimaging Integrated Solution, Inc.

K number K223739

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HKX 2019-12-06

Intraocular Pressure Tonometer EASYTON

Applicant Company Elamed

K number K190382

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HKX 2019-06-21

MiiS Horus Scope DPT 100

Applicant Medimaging Integrated Solution, Inc (Miis)

K number K181260

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HKX 2019-02-08

Keeler TonoCare Tonometer

Applicant Keeler Instruments, Inc.

K number K181143

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HKX 2018-12-14

Tono Vue Non-Contact Tonometer

Applicant Crystalvue Medical Corporation

K number K180820

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HKX 2017-04-24

VX130 Ophthalmic Diagnostic Device

Applicant Luneau Sas

K number K162067

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HKX 2012-11-08

CORVIS ST

Applicant Oculus Optikgerate GmbH

K number K113066

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HKX 2011-09-20

FULL AUTO TONOMETER MODEL TX-20

Applicant Canon Inc. -Medical Equipment Group

K number K111710

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HKX 2010-12-10

PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000

Applicant Keeler Instruments, Inc.

K number K093298

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HKX 2009-07-27

ACCUPEN

Applicant Accutome Ultrasound, Inc.

K number K083377

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HKX 2008-11-18

NON-CONTACT TONOMETER, MODEL FT-1000

Applicant Tomey Corporation

K number K073087

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HKX 2008-08-07

OCULAR RESPONSE ANALYZER

Applicant Reichert, Inc.

K number K081756

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HKX 2006-06-09

KOWA KT-800

Applicant Kowa Co. , Ltd.

K number K053444

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HKX 2006-04-06

TONOMETER DIATON

Applicant Ryazan State Instruments

K number K060780

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HKX 2004-12-10

TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)

Applicant Retinapharma Technologies, Inc.

K number K042099

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HKX 2004-01-20

NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER

Applicant Reichert, Inc.

K number K032799

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HKX 2003-12-04

NON-CONTACT TONOMETER, MODEL NT-4000

Applicant Nidek, Inc.

K number K031733

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HKX 2003-04-24

APPLANATION TONOMETER

Applicant Optilasa, S.L.

K number K023676

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HKX 2002-11-26

CANON FULL AUTO TONOMETER TX-F

Applicant Canon, Inc.-Utsunomiya Optical Products Operation

K number K023816

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HKX 2002-10-11

TGDC-01 PRA

Applicant Truevision Instruments

K number K021937

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HKX 2002-10-11

KOWA AUTOMATED TONOMETER KT-500

Applicant Kowa Optimed, Inc.

K number K013805

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HKX 2002-02-20

PORTABLE NON-CONTACT TONOMETER, MODEL PT100

Applicant Leica Microsystems, Inc. O.I.D.

K number K013259

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HKX 2001-06-27

LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201

Applicant Langham Ophthalmic Technologies

K number K010998

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HKX 2000-12-11

MODEL 30 CLASSIC PNEUMATONOMETER

Applicant Xomed, Inc.

K number K002395

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HKX 2000-10-18

SMARTLENS

Applicant Odc Ophthalmic Development Co. AG

K number K002510

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HKX 1999-06-07

LEICA AT550

Applicant Leica Microsystems, Inc.

K number K990869

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HKX 1999-03-25

KEELER PULSAIR 3000 NON CONTACT TONOMETER

Applicant Keeler Instruments, Inc.

K number K990257

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HKX 1997-03-03

CANON TX-10 TONOMETER

Applicant Canon USA, Inc.

K number K963079

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HKX 1995-08-22

ZEIMER SELF TONOMETER

Applicant Cds Technologies

K number K953031

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HKX 1995-08-17

DIGITAL AVERAGING TONOMETER

Applicant Opti-Med Electronics

K number K945972

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HKX 1995-05-12

NON-CONTACT TONOMETER T-2

Applicant Canon, Inc.

K number K943939

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HKX 1994-09-29

XPERT NCT

Applicant Reichert Ophthalmic Instruments, Div. Leica, Inc.

K number K941865

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HKX 1993-06-22

TIP & MEMBRANE ASSEMBLY

Applicant Bio-Rad

K number K921443

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HKX 1993-04-05

BURTON APPLANATION TONOMETER - MODEL T850 & T1000

Applicant R.H. Burton Co.

K number K924777

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HKX 1992-08-05

CYLINDER OF GAS, CAN OF GAS (CC12F2)

Applicant Bio-Rad

K number K921617

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HKX 1991-10-15

NIDEK MODEL NT-1000

Applicant Nidek, Inc.

K number K913189

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HKX 1991-06-25

KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION

Applicant Keeler Instruments, Inc.

K number K911721

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HKX 1989-10-31

BIO-RAD MODULAR AIR COMPRESSOR

Applicant Bio-Rad

K number K895575

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HKX 1989-01-06

MMAC II TONOMETER

Applicant Professional Technologies Corp.

K number K884012

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HKX 1987-11-02

TONOMETER TAPES

Applicant Richmond Products, Inc.

K number K873917

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HKX 1987-11-02

OBF MODEL 115 COMPUTER TONOMETER SYSTEM

Applicant Ocular Blood Flow Laboratories, Inc.

K number K873422

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HKX 1987-06-03

T P C (TONOMETER PROBE COVER)

Applicant Krb Ent.

K number K871935

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HKX 1987-05-18

TOPCON COMPUTERIZED TONOMETER CT-10

Applicant Topcon Instrument Corporation of America

K number K871335

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HKX 1987-03-17

KEELER PULSAIR NON CONTACT TONOMETER

Applicant Keeler Instruments, Inc.

K number K870750

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HKX 1987-02-20

DIGILAB MICRO ONE APPLANATION TONOMETER

Applicant Bio-Rad

K number K870121

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HKX 1987-02-12

OBF MODEL 112 VACUUM CUP SYSTEM

Applicant Ocular Blood Flow Laboratories, Inc.

K number K864959

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HKX 1986-09-25

SURGICAL IOP MONITOR

Applicant Ameritek, Inc.

K number K863235

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HKX 1986-09-24

DIGILAB MODULAR ONE-APPLANATION TONOMETER

Applicant Bio-Rad

K number K863217

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HKX 1986-09-03

COMPUTON(R)

Applicant Optical Radiation Corp.

K number K863200

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HKX 1984-11-19

EPISCLERAL VENOUS PRESSURE

Applicant Eyetech, LLC

K number K843354

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HKX 1984-08-02

WOODLYN APPLANATION TONOMETER

Applicant Woodlyn, Inc.

K number K841762

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HKX 1984-06-19

CAT 100

Applicant CooperVision, Inc.

K number K840836

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HKX 1984-01-04

CLERZ LUBRICATING/REWETTING SOLUTION

Applicant CooperVision, Inc.

K number K833494

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HKX 1982-04-09

GLAUKON

Applicant Sonometrics Systems, Inc.

K number K820751

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HKX 1980-11-12

AO NON-CONTACT II TONOMETER

Applicant American Optical Corp.

K number K802419

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HKX 1980-08-04

SPAN-AID BRIDGING PILLOW SYSTEM

Applicant Span-America Medical Systems, Inc.

K number K801518

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