FDA Product Code
FDA Product Code HKY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.1930
510(k) Clearances — 56 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241447 | iCare ST500 (TA04) | Icare Finland OY | 2024-09-27 | Traditional | PDF ↗ |
| K233516 | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) | Reichert, Inc. | 2024-05-01 | Traditional | PDF ↗ |
| K234037 | CATS-L Tonometer Prism | Cats Tonometer, LLC | 2024-02-09 | Special | PDF ↗ |
| K232143 | Applanation Tonometer HT-5000 | Huvitz Co., Ltd. | 2023-10-23 | Traditional | PDF ↗ |
| K220852 | iCare IC200 | Icare Finland OY | 2022-10-06 | Traditional | PDF ↗ |
| K211355 | iCare HOME2 | Icare Finland OY | 2022-01-25 | Traditional | PDF ↗ |
| K203850 | CATS®-D Tonometer Prism | Cats Tonometer, LLC | 2021-06-14 | Traditional | PDF ↗ |
| K200966 | Icare HOME Tonometer | Icare Finland OY | 2020-05-07 | Special | PDF ↗ |
| K190316 | Icare ic200 | Icare Finland OY | 2020-01-14 | Traditional | PDF ↗ |
| K191314 | Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 2019-12-19 | Traditional | PDF ↗ |
| K182491 | Applanation tonometer AT-2 | Takagi Seiko Co., Ltd. | 2018-12-10 | Traditional | PDF ↗ |
| K180839 | AT 030 | Carl Zeiss Meditec, AG | 2018-06-07 | Traditional | PDF ↗ |
| K173904 | CATS Tonometer Prism | Cats Tonometer, LLC | 2018-03-09 | Traditional | PDF ↗ |
| K172728 | Applanation tonometer AT-1 | Takagi Seiko Co., Ltd. | 2017-10-17 | Traditional | PDF ↗ |
| K163343 | Icare HOME tonometer | Icare Finland OY | 2017-03-21 | Traditional | PDF ↗ |
| K153694 | Icare ic100 | Icare Finland OY | 2016-04-19 | Traditional | PDF ↗ |
| K142263 | Applanation Tonometer | Shanghai Mediworks Precision Instruments Co. , Ltd. | 2016-04-15 | Traditional | PDF ↗ |
| K151491 | Falck Medical Multifunction Tonometer, FAT1 | Falck Medical, Inc. | 2016-01-15 | Traditional | PDF ↗ |
| K152644 | KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 | Keeler Limited | 2015-12-31 | Special | PDF ↗ |
| K152308 | Sensor Medical Single Use Tonometer Prism | Sensor Medical Technology, LLC | 2015-10-13 | Traditional | PDF ↗ |
| K142179 | D-KAT Z-YPE | Keeler, Ltd. | 2014-09-17 | Special | PDF ↗ |
| K132549 | ACCUTIP COVER | Accutome, Inc. | 2014-04-23 | Traditional | PDF ↗ |
| K133234 | T-TYPE D-KAT, R-TYPE D-KAT | Keeler Limited | 2014-02-21 | Traditional | PDF ↗ |
| K132917 | OCULAR FORCE GAUGE | Ocular Therapeutix, Inc. | 2013-12-20 | Traditional | PDF ↗ |
| K093445 | KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT) | Keeler, Ltd. | 2010-01-19 | Abbreviated | PDF ↗ |
| K071755 | FALCK APPLANATION TONOMETER (FAT2) | Falck Medical, Inc. | 2008-06-03 | Traditional | PDF ↗ |
| K063873 | ICARE TONOMETER TA01I | Tiolat OY | 2007-05-23 | Traditional | PDF ↗ |
| K070534 | MODIFICATION TO: OCU-FILM TIP COVER | Reichert, Inc. | 2007-03-27 | Special | PDF ↗ |
| K053430 | TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER | Medtronic Xomed, Inc. | 2006-03-03 | Traditional | PDF ↗ |
| K033146 | TONO-PEN TONOMETER TIP COVER | Tra & Accessories | 2004-11-23 | Traditional | PDF ↗ |
| K032967 | PASCAL DYNAMIC CONTOUR TONOMETER | Smt Swiss Microtechnology AG | 2003-11-14 | Traditional | PDF ↗ |
| K032769 | EYESOPEN TONOMETER | Eye-Deas, LLC | 2003-09-23 | Traditional | PDF ↗ |
| K023838 | LUNEAU STERILE TONOMETER SEPARATION PRISMS | Luneau SA | 2003-02-20 | Traditional | PDF ↗ |
| K022054 | F 900 | C.S.O. S.R.L. | 2002-08-06 | Traditional | PDF ↗ |
| K011199 | PROVIEW EYE PRESSURE MONITOR | Bausch & Lomb, Inc. | 2001-07-02 | Traditional | PDF ↗ |
| K992835 | C.S.O. TONOMETER | Cso | 2000-06-06 | Traditional | PDF ↗ |
| K000288 | REICHERT CT200 CONTACT TONOMETER | Reichert Ophthalmic Instruments, Div. Leica, Inc. | 2000-03-23 | Traditional | PDF ↗ |
| K991840 | FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER | Bernard B. Fresco | 2000-03-20 | Traditional | PDF ↗ |
| K992998 | AUTOMATED OPHTHALMICS SOFTIPS | Automated Ophthalmics, Inc. | 2000-01-10 | Traditional | PDF ↗ |
| K981432 | GOLDMAN MANUAL TONOMETER | Golden Vision, Inc. | 1999-01-12 | Traditional | PDF ↗ |
| K970887 | BLOOD FLOW ANALYZER | Paradigm Medical Industries, Inc. | 1997-06-17 | Traditional | PDF ↗ |
| K964312 | MENTOR TONO-PEN 3 | Mentor Ophthalmics, Inc. | 1996-11-26 | Traditional | PDF ↗ |
| K961512 | PERKINS HAND-HELD APPLANATION TONOMETER | Clement Clarke, Inc. | 1996-07-18 | Traditional | PDF ↗ |
| K960924 | KOWA HAND-HELD APPLANATION TONOMETER HA-1 | Kowa Optimed, Inc. | 1996-06-04 | Traditional | PDF ↗ |
| K945446 | BOBES TONOMETER | Bobes S.A. | 1995-06-20 | Traditional | PDF ↗ |
| K945541 | SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE | Rudolf Riester GmbH & Co. KG | 1995-05-08 | Traditional | PDF ↗ |
| K924760 | TOMEY PROTON TONOMETER | Tomey Corporation USA | 1993-04-05 | Traditional | PDF ↗ |
| K923877 | TONOSHIELD TONOMETER SHIELD | Oasis Medical, Inc. | 1992-09-30 | Traditional | PDF ↗ |
| K882750 | OCU-FILM TIP COVER | Oculab, Inc. | 1988-08-04 | Traditional | PDF ↗ |
| K860330 | MAKLAKOV STYLE TONOMETER | Med-Tech Develoment Corp. | 1986-02-12 | Traditional | PDF ↗ |
| K852774 | OCULAB TONOPEN | Oculab, Inc. | 1985-08-20 | Traditional | PDF ↗ |
| K834187 | JAKOBI SURG. INSTRUMENTS #6 50 | Imm Enterprises , Ltd. | 1984-03-05 | Traditional | PDF ↗ |
| K832996 | SURGICAL IOP MONITOR | Miami Eye Technology, Inc. | 1983-11-28 | Traditional | PDF ↗ |
| K813619 | CONPHAR-SCHIOETZ TONOMETER | Conphar, Inc. | 1982-02-24 | Traditional | PDF ↗ |
| K781105 | TONOMETER, DIGITON | Ical, Inc. | 1978-09-27 | Traditional | PDF ↗ |
| K772130 | OCULAR CEREBRAL VASCULAR MONITOR | Digilab, Inc. | 1977-11-28 | Traditional | PDF ↗ |
Product code HKY · Class II · Ophthalmic. Data: openFDA.