FDA 510(k) Applications for Medical Device Product Code "HKY"
(Tonometer, Manual)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K132549 | ACCUTOME, INC. | ACCUTIP COVER | 04/23/2014 |
| K992998 | AUTOMATED OPHTHALMICS, INC. | AUTOMATED OPHTHALMICS SOFTIPS | 01/10/2000 |
| K011199 | BAUSCH & LOMB, INC. | PROVIEW EYE PRESSURE MONITOR | 07/02/2001 |
| K991840 | BERNARD B. FRESCO | FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER | 03/20/2000 |
| K022054 | C.S.O. S.R.L. | F 900 | 08/06/2002 |
| K180839 | Carl Zeiss Meditec AG | AT 030 | 06/07/2018 |
| K203850 | CATS Tonometer LLC | CATS«-D Tonometer Prism | 06/14/2021 |
| K173904 | CATS Tonometer, LLC | CATS Tonometer Prism | 03/09/2018 |
| K191314 | Chongqing Sunkingdom Medical Instrument Co., Ltd | Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q | 12/19/2019 |
| K961512 | CLEMENT CLARKE, INC. | PERKINS HAND-HELD APPLANATION TONOMETER | 07/18/1996 |
| K992835 | CSO | C.S.O. TONOMETER | 06/06/2000 |
| K032769 | EYE-DEAS, LLC | EYESOPEN TONOMETER | 09/23/2003 |
| K071755 | FALCK MEDICAL INC. | FALCK APPLANATION TONOMETER (FAT2) | 06/03/2008 |
| K151491 | FALCK MEDICAL, INC | Falck Medical Multifunction Tonometer, FAT1 | 01/15/2016 |
| K981432 | GOLDEN VISION, INC. | GOLDMAN MANUAL TONOMETER | 01/12/1999 |
| K163343 | Icare Finland Oy | Icare HOME tonometer | 03/21/2017 |
| K200966 | Icare Finland Oy | Icare HOME Tonometer | 05/07/2020 |
| K211355 | Icare Finland Oy | iCare HOME2 | 01/25/2022 |
| K153694 | Icare Finland Oy | Icare ic100 | 04/19/2016 |
| K190316 | Icare Finland Oy | Icare ic200 | 01/14/2020 |
| K220852 | Icare Finland Oy | iCare IC200 | 10/06/2022 |
| K152644 | KEELER LIMITED | KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 | 12/31/2015 |
| K133234 | KEELER LIMITED | T-TYPE D-KAT, R-TYPE D-KAT | 02/21/2014 |
| K142179 | KEELER LTD. | D-KAT Z-YPE | 09/17/2014 |
| K093445 | KEELER LTD. | KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT) | 01/19/2010 |
| K960924 | KOWA OPTIMED, INC. | KOWA HAND-HELD APPLANATION TONOMETER HA-1 | 06/04/1996 |
| K023838 | LUNEAU SA | LUNEAU STERILE TONOMETER SEPARATION PRISMS | 02/20/2003 |
| K053430 | MEDTRONIC XOMED, INC. | TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER | 03/03/2006 |
| K964312 | MENTOR OPHTHALMICS, INC. | MENTOR TONO-PEN 3 | 11/26/1996 |
| K132917 | OCULAR THERAPEUTIX, INC. | OCULAR FORCE GAUGE | 12/20/2013 |
| K970887 | PARADIGM MEDICAL INDUSTRIES, INC. | BLOOD FLOW ANALYZER | 06/17/1997 |
| K000288 | REICHERT OPHTHALMIC INSTRUMENTS, DIV. LEICA, INC. | REICHERT CT200 CONTACT TONOMETER | 03/23/2000 |
| K070534 | REICHERT, INC. | MODIFICATION TO: OCU-FILM TIP COVER | 03/27/2007 |
| K152308 | SENSOR MEDICAL TECHNOLOGY, LLC | Sensor Medical Single Use Tonometer Prism | 10/13/2015 |
| K142263 | SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD. | Applanation Tonometer | 04/15/2016 |
| K032967 | SMT SWISS MICROTECHNOLOGY AG | PASCAL DYNAMIC CONTOUR TONOMETER | 11/14/2003 |
| K172728 | TAKAGI SEIKO CO., LTD. | Applanation tonometer AT-1 | 10/17/2017 |
| K182491 | Takagi Seiko Co., Ltd. | Applanation tonometer AT-2 | 12/10/2018 |
| K063873 | TIOLAT OY | ICARE TONOMETER TA01I | 05/23/2007 |
| K033146 | TRA & ACCESSORIES | TONO-PEN TONOMETER TIP COVER | 11/23/2004 |
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