Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Tonometer, Manual

FDA product code HKY · 51 cleared devices

Class 2 Ophthalmic

Regulation: 21 CFR 886.1930
Review panel: OP
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-11-28 – 2024-09-27

HKY 2024-09-27

iCare ST500 (TA04)

Applicant Icare Finland OY

K number K241447

View details →

HKY 2024-05-01

Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)

Applicant Reichert, Inc.

K number K233516

View details →

HKY 2024-02-09

CATS-L Tonometer™ Prism

Applicant Cats Tonometer, LLC

K number K234037

View details →

HKY 2023-10-23

Applanation Tonometer HT-5000

Applicant Huvitz Co., Ltd.

K number K232143

View details →

HKY 2022-10-06

iCare IC200

Applicant Icare Finland OY

K number K220852

View details →

HKY 2022-01-25

iCare HOME2

Applicant Icare Finland OY

K number K211355

View details →

HKY 2021-06-14

CATS®-D Tonometer Prism

Applicant Cats Tonometer, LLC

K number K203850

View details →

HKY 2020-05-07

Icare HOME Tonometer

Applicant Icare Finland OY

K number K200966

View details →

HKY 2020-01-14

Icare ic200

Applicant Icare Finland OY

K number K190316

View details →

HKY 2019-12-19

Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q

Applicant Chongqing Sunkingdom Medical Instrument Co., Ltd.

K number K191314

View details →

HKY 2018-12-10

Applanation tonometer AT-2

Applicant Takagi Seiko Co., Ltd.

K number K182491

View details →

HKY 2018-06-07

AT 030

Applicant Carl Zeiss Meditec, AG

K number K180839

View details →

HKY 2018-03-09

CATS Tonometer Prism

Applicant Cats Tonometer, LLC

K number K173904

View details →

HKY 2017-10-17

Applanation tonometer AT-1

Applicant Takagi Seiko Co., Ltd.

K number K172728

View details →

HKY 2017-03-21

Icare HOME tonometer

Applicant Icare Finland OY

K number K163343

View details →

HKY 2016-04-19

Icare ic100

Applicant Icare Finland OY

K number K153694

View details →

HKY 2016-04-15

Applanation Tonometer

Applicant Shanghai Mediworks Precision Instruments Co. , Ltd.

K number K142263

View details →

HKY 2016-01-15

Falck Medical Multifunction Tonometer, FAT1

Applicant Falck Medical, Inc.

K number K151491

View details →

HKY 2013-12-20

OCULAR FORCE GAUGE

Applicant Ocular Therapeutix, Inc.

K number K132917

View details →

HKY 2010-01-19

KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT)

Applicant Keeler, Ltd.

K number K093445

View details →

HKY 2008-06-03

FALCK APPLANATION TONOMETER (FAT2)

Applicant Falck Medical, Inc.

K number K071755

View details →

HKY 2007-05-23

ICARE TONOMETER TA01I

Applicant Tiolat OY

K number K063873

View details →

HKY 2007-03-27

MODIFICATION TO: OCU-FILM TIP COVER

Applicant Reichert, Inc.

K number K070534

View details →

HKY 2006-03-03

TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER

Applicant Medtronic Xomed, Inc.

K number K053430

View details →

HKY 2004-11-23

TONO-PEN TONOMETER TIP COVER

Applicant Tra & Accessories

K number K033146

View details →

HKY 2003-11-14

PASCAL DYNAMIC CONTOUR TONOMETER

Applicant Smt Swiss Microtechnology AG

K number K032967

View details →

HKY 2003-09-23

EYESOPEN TONOMETER

Applicant Eye-Deas, LLC

K number K032769

View details →

HKY 2003-02-20

LUNEAU STERILE TONOMETER SEPARATION PRISMS

Applicant Luneau SA

K number K023838

View details →

HKY 2002-08-06

F 900

Applicant C.S.O. S.R.L.

K number K022054

View details →

HKY 2001-07-02

PROVIEW EYE PRESSURE MONITOR

Applicant Bausch & Lomb, Inc.

K number K011199

View details →

HKY 2000-06-06

C.S.O. TONOMETER

Applicant Cso

K number K992835

View details →

HKY 2000-03-23

REICHERT CT200 CONTACT TONOMETER

Applicant Reichert Ophthalmic Instruments, Div. Leica, Inc.

K number K000288

View details →

HKY 2000-03-20

FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER

Applicant Bernard B. Fresco

K number K991840

View details →

HKY 2000-01-10

AUTOMATED OPHTHALMICS SOFTIPS

Applicant Automated Ophthalmics, Inc.

K number K992998

View details →

HKY 1999-01-12

GOLDMAN MANUAL TONOMETER

Applicant Golden Vision, Inc.

K number K981432

View details →

HKY 1997-06-17

BLOOD FLOW ANALYZER

Applicant Paradigm Medical Industries, Inc.

K number K970887

View details →

HKY 1996-11-26

MENTOR TONO-PEN 3

Applicant Mentor Ophthalmics, Inc.

K number K964312

View details →

HKY 1996-07-18

PERKINS HAND-HELD APPLANATION TONOMETER

Applicant Clement Clarke, Inc.

K number K961512

View details →

HKY 1996-06-04

KOWA HAND-HELD APPLANATION TONOMETER HA-1

Applicant Kowa Optimed, Inc.

K number K960924

View details →

HKY 1995-06-20

BOBES TONOMETER

Applicant Bobes S.A.

K number K945446

View details →

HKY 1995-05-08

SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE

Applicant Rudolf Riester GmbH & Co. KG

K number K945541

View details →

HKY 1993-04-05

TOMEY PROTON TONOMETER

Applicant Tomey Corporation USA

K number K924760

View details →

HKY 1992-09-30

TONOSHIELD TONOMETER SHIELD

Applicant Oasis Medical, Inc.

K number K923877

View details →

HKY 1988-08-04

OCU-FILM TIP COVER

Applicant Oculab, Inc.

K number K882750

View details →

HKY 1986-02-12

MAKLAKOV STYLE TONOMETER

Applicant Med-Tech Develoment Corp.

K number K860330

View details →

HKY 1985-08-20

OCULAB TONOPEN

Applicant Oculab, Inc.

K number K852774

View details →

HKY 1984-03-05

JAKOBI SURG. INSTRUMENTS #6 50

Applicant Imm Enterprises , Ltd.

K number K834187

View details →

HKY 1983-11-28

SURGICAL IOP MONITOR

Applicant Miami Eye Technology, Inc.

K number K832996

View details →

HKY 1982-02-24

CONPHAR-SCHIOETZ TONOMETER

Applicant Conphar, Inc.

K number K813619

View details →

HKY 1978-09-27

TONOMETER, DIGITON

Applicant Ical, Inc.

K number K781105

View details →

HKY 1977-11-28

OCULAR CEREBRAL VASCULAR MONITOR

Applicant Digilab, Inc.

K number K772130

View details →

↑