FDA Product Code
FDA Product Code HKX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.1930
510(k) Clearances — 58 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253039 | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | Topcon Corporation | 2025-11-07 | Traditional | PDF ↗ |
| K223739 | VS Tabletop Tonometer | Medimaging Integrated Solution, Inc. | 2023-11-08 | Traditional | PDF ↗ |
| K190382 | Intraocular Pressure Tonometer EASYTON | Company Elamed | 2019-12-06 | Traditional | PDF ↗ |
| K181260 | MiiS Horus Scope DPT 100 | Medimaging Integrated Solution, Inc (Miis) | 2019-06-21 | Traditional | PDF ↗ |
| K181143 | Keeler TonoCare Tonometer | Keeler Instruments, Inc. | 2019-02-08 | Traditional | PDF ↗ |
| K180820 | Tono Vue Non-Contact Tonometer | Crystalvue Medical Corporation | 2018-12-14 | Traditional | PDF ↗ |
| K162067 | VX130 Ophthalmic Diagnostic Device | Luneau Sas | 2017-04-24 | Traditional | PDF ↗ |
| K143086 | VX120 Ophthalmic Diagnostic Device | Luneau Sas | 2015-06-01 | Traditional | PDF ↗ |
| K113066 | CORVIS ST | Oculus Optikgerate GmbH | 2012-11-08 | Traditional | PDF ↗ |
| K111710 | FULL AUTO TONOMETER MODEL TX-20 | Canon Inc. -Medical Equipment Group | 2011-09-20 | Special | PDF ↗ |
| K093298 | PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 | Keeler Instruments, Inc. | 2010-12-10 | Traditional | PDF ↗ |
| K083377 | ACCUPEN | Accutome Ultrasound, Inc. | 2009-07-27 | Traditional | PDF ↗ |
| K073087 | NON-CONTACT TONOMETER, MODEL FT-1000 | Tomey Corporation | 2008-11-18 | Traditional | PDF ↗ |
| K081756 | OCULAR RESPONSE ANALYZER | Reichert, Inc. | 2008-08-07 | Traditional | PDF ↗ |
| K053444 | KOWA KT-800 | Kowa Co. , Ltd. | 2006-06-09 | Traditional | PDF ↗ |
| K060780 | TONOMETER DIATON | Ryazan State Instruments | 2006-04-06 | Traditional | PDF ↗ |
| K042099 | TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) | Retinapharma Technologies, Inc. | 2004-12-10 | Traditional | PDF ↗ |
| K032799 | NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER | Reichert, Inc. | 2004-01-20 | Traditional | PDF ↗ |
| K031733 | NON-CONTACT TONOMETER, MODEL NT-4000 | Nidek, Inc. | 2003-12-04 | Traditional | PDF ↗ |
| K023676 | APPLANATION TONOMETER | Optilasa, S.L. | 2003-04-24 | Traditional | PDF ↗ |
| K023816 | CANON FULL AUTO TONOMETER TX-F | Canon, Inc.-Utsunomiya Optical Products Operation | 2002-11-26 | Traditional | PDF ↗ |
| K021937 | TGDC-01 PRA | Truevision Instruments | 2002-10-11 | Traditional | PDF ↗ |
| K013805 | KOWA AUTOMATED TONOMETER KT-500 | Kowa Optimed, Inc. | 2002-10-11 | Traditional | PDF ↗ |
| K013259 | PORTABLE NON-CONTACT TONOMETER, MODEL PT100 | Leica Microsystems, Inc. O.I.D. | 2002-02-20 | Traditional | PDF ↗ |
| K010998 | LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201 | Langham Ophthalmic Technologies | 2001-06-27 | Traditional | PDF ↗ |
| K002395 | MODEL 30 CLASSIC PNEUMATONOMETER | Xomed, Inc. | 2000-12-11 | Traditional | PDF ↗ |
| K002510 | SMARTLENS | Odc Ophthalmic Development Co. AG | 2000-10-18 | Traditional | PDF ↗ |
| K990869 | LEICA AT550 | Leica Microsystems, Inc. | 1999-06-07 | Traditional | PDF ↗ |
| K990257 | KEELER PULSAIR 3000 NON CONTACT TONOMETER | Keeler Instruments, Inc. | 1999-03-25 | Traditional | PDF ↗ |
| K963079 | CANON TX-10 TONOMETER | Canon USA, Inc. | 1997-03-03 | Traditional | PDF ↗ |
| K953031 | ZEIMER SELF TONOMETER | Cds Technologies | 1995-08-22 | Traditional | PDF ↗ |
| K945972 | DIGITAL AVERAGING TONOMETER | Opti-Med Electronics | 1995-08-17 | Traditional | PDF ↗ |
| K943939 | NON-CONTACT TONOMETER T-2 | Canon, Inc. | 1995-05-12 | Traditional | PDF ↗ |
| K941865 | XPERT NCT | Reichert Ophthalmic Instruments, Div. Leica, Inc. | 1994-09-29 | Traditional | PDF ↗ |
| K921443 | TIP & MEMBRANE ASSEMBLY | Bio-Rad | 1993-06-22 | Traditional | PDF ↗ |
| K924777 | BURTON APPLANATION TONOMETER - MODEL T850 & T1000 | R.H. Burton Co. | 1993-04-05 | Traditional | PDF ↗ |
| K921617 | CYLINDER OF GAS, CAN OF GAS (CC12F2) | Bio-Rad | 1992-08-05 | Traditional | PDF ↗ |
| K913189 | NIDEK MODEL NT-1000 | Nidek, Inc. | 1991-10-15 | Traditional | PDF ↗ |
| K911721 | KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION | Keeler Instruments, Inc. | 1991-06-25 | Traditional | PDF ↗ |
| K895575 | BIO-RAD MODULAR AIR COMPRESSOR | Bio-Rad | 1989-10-31 | Traditional | PDF ↗ |
| K884012 | MMAC II TONOMETER | Professional Technologies Corp. | 1989-01-06 | Traditional | PDF ↗ |
| K873422 | OBF MODEL 115 COMPUTER TONOMETER SYSTEM | Ocular Blood Flow Laboratories, Inc. | 1987-11-02 | Traditional | PDF ↗ |
| K873917 | TONOMETER TAPES | Richmond Products, Inc. | 1987-11-02 | Traditional | PDF ↗ |
| K871935 | T P C (TONOMETER PROBE COVER) | Krb Ent. | 1987-06-03 | Traditional | PDF ↗ |
| K871335 | TOPCON COMPUTERIZED TONOMETER CT-10 | Topcon Instrument Corporation of America | 1987-05-18 | Traditional | PDF ↗ |
| K870750 | KEELER PULSAIR NON CONTACT TONOMETER | Keeler Instruments, Inc. | 1987-03-17 | Traditional | PDF ↗ |
| K870121 | DIGILAB MICRO ONE APPLANATION TONOMETER | Bio-Rad | 1987-02-20 | Traditional | PDF ↗ |
| K864959 | OBF MODEL 112 VACUUM CUP SYSTEM | Ocular Blood Flow Laboratories, Inc. | 1987-02-12 | Traditional | PDF ↗ |
| K863235 | SURGICAL IOP MONITOR | Ameritek, Inc. | 1986-09-25 | Traditional | PDF ↗ |
| K863217 | DIGILAB MODULAR ONE-APPLANATION TONOMETER | Bio-Rad | 1986-09-24 | Traditional | PDF ↗ |
| K863200 | COMPUTON(R) | Optical Radiation Corp. | 1986-09-03 | Traditional | PDF ↗ |
| K843354 | EPISCLERAL VENOUS PRESSURE | Eyetech, LLC | 1984-11-19 | Traditional | PDF ↗ |
| K841762 | WOODLYN APPLANATION TONOMETER | Woodlyn, Inc. | 1984-08-02 | Traditional | PDF ↗ |
| K840836 | CAT 100 | CooperVision, Inc. | 1984-06-19 | Traditional | PDF ↗ |
| K833494 | CLERZ LUBRICATING/REWETTING SOLUTION | CooperVision, Inc. | 1984-01-04 | Traditional | PDF ↗ |
| K820751 | GLAUKON | Sonometrics Systems, Inc. | 1982-04-09 | Traditional | PDF ↗ |
| K802419 | AO NON-CONTACT II TONOMETER | American Optical Corp. | 1980-11-12 | Traditional | PDF ↗ |
| K801518 | SPAN-AID BRIDGING PILLOW SYSTEM | Span-America Medical Systems, Inc. | 1980-08-04 | Traditional | PDF ↗ |
Product code HKX · Class II · Ophthalmic. Data: openFDA.