Panels › Ophthalmic › Product code HKX · Class 2
Tonometer, Ac-Powered
Regulation 886.1930
1510(k)s in 12 months (58 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HKX
| Company | 510(k)s | Recalls |
|---|---|---|
| Bio-Rad | 5 | 0 |
| Keeler Instruments, Inc. | 5 | 0 |
| Canon USA, Inc. | 2 | 0 |
| CooperVision, Inc. | 2 | 0 |
| Luneau Sas | 2 | 0 |
| Nidek, Inc. | 2 | 0 |
| Ocular Blood Flow Laboratories, Inc. | 2 | 0 |
| Reichert, Inc. | 2 | 0 |
| Accutome Ultrasound, Inc. | 1 | 0 |
| American Optical Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 7, 2025 | K253039 | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA Topcon Corporation, JP | HKX |
| Nov 8, 2023 | K223739 | VS Tabletop Tonometer Medimaging Integrated Solution, Inc., CN | HKX |
| Dec 6, 2019 | K190382 | Intraocular Pressure Tonometer EASYTON Company Elamed, RU | HKX |
| Jun 21, 2019 | K181260 | MiiS Horus Scope DPT 100 Medimaging Integrated Solution, Inc (Miis), CN | HKX |
| Feb 8, 2019 | K181143 | Keeler TonoCare Tonometer Keeler Instruments, Inc. | HKX |
| Dec 14, 2018 | K180820 | Tono Vue Non-Contact Tonometer Crystalvue Medical Corporation, TW | HKX |
| Apr 24, 2017 | K162067 | VX130 Ophthalmic Diagnostic Device Luneau Sas, FR | HKX |
| Jun 1, 2015 | K143086 | VX120 Ophthalmic Diagnostic Device Luneau Sas, FR | HKX |
| Nov 8, 2012 | K113066 | CORVIS ST Oculus Optikgerate GmbH, DE | HKX |
| Sep 20, 2011 | K111710 | FULL AUTO TONOMETER MODEL TX-20 Canon Inc. -Medical Equipment Group, JP | HKX |
| Dec 10, 2010 | K093298 | PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 Keeler Instruments, Inc. | HKX |
| Jul 27, 2009 | K083377 | ACCUPEN Accutome Ultrasound, Inc. | HKX |
| Nov 18, 2008 | K073087 | NON-CONTACT TONOMETER, MODEL FT-1000 Tomey Corporation, JP | HKX |
| Aug 7, 2008 | K081756 | OCULAR RESPONSE ANALYZER Reichert, Inc. | HKX |
| Jun 9, 2006 | K053444 | KOWA KT-800 Kowa Co. , Ltd., JP | HKX |
| Apr 6, 2006 | K060780 | TONOMETER DIATON Ryazan State Instruments | HKX |
| Dec 10, 2004 | K042099 | TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) Retinapharma Technologies, Inc. | HKX |
| Jan 20, 2004 | K032799 | NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER Reichert, Inc. | HKX |
| Dec 4, 2003 | K031733 | NON-CONTACT TONOMETER, MODEL NT-4000 Nidek, Inc. | HKX |
| Apr 24, 2003 | K023676 | APPLANATION TONOMETER Optilasa, S.L., ES | HKX |
| Nov 26, 2002 | K023816 | CANON FULL AUTO TONOMETER TX-F Canon, Inc.-Utsunomiya Optical Products Operation | HKX |
| Oct 11, 2002 | K021937 | TGDC-01 PRA Truevision Instruments | HKX |
| Oct 11, 2002 | K013805 | KOWA AUTOMATED TONOMETER KT-500 Kowa Optimed, Inc. | HKX |
| Feb 20, 2002 | K013259 | PORTABLE NON-CONTACT TONOMETER, MODEL PT100 Leica Microsystems, Inc. O.I.D. | HKX |
| Jun 27, 2001 | K010998 | LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201 Langham Ophthalmic Technologies | HKX |
| Dec 11, 2000 | K002395 | MODEL 30 CLASSIC PNEUMATONOMETER Xomed, Inc. | HKX |
| Oct 18, 2000 | K002510 | SMARTLENS Odc Ophthalmic Development Co. AG | HKX |
| Jun 7, 1999 | K990869 | LEICA AT550 Leica Microsystems, Inc. | HKX |
| Mar 25, 1999 | K990257 | KEELER PULSAIR 3000 NON CONTACT TONOMETER Keeler Instruments, Inc. | HKX |
| Mar 3, 1997 | K963079 | CANON TX-10 TONOMETER Canon USA, Inc. | HKX |
| Aug 22, 1995 | K953031 | ZEIMER SELF TONOMETER Cds Technologies | HKX |
| Aug 17, 1995 | K945972 | DIGITAL AVERAGING TONOMETER Opti-Med Electronics | HKX |
| May 12, 1995 | K943939 | NON-CONTACT TONOMETER T-2 Canon, Inc., JP | HKX |
| Sep 29, 1994 | K941865 | XPERT NCT Reichert Ophthalmic Instruments, Div. Leica, Inc. | HKX |
| Jun 22, 1993 | K921443 | TIP & MEMBRANE ASSEMBLY Bio-Rad | HKX |
| Apr 5, 1993 | K924777 | BURTON APPLANATION TONOMETER - MODEL T850 & T1000 R.H. Burton Co. | HKX |
| Aug 5, 1992 | K921617 | CYLINDER OF GAS, CAN OF GAS (CC12F2) Bio-Rad | HKX |
| Oct 15, 1991 | K913189 | NIDEK MODEL NT-1000 Nidek, Inc. | HKX |
| Jun 25, 1991 | K911721 | KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION Keeler Instruments, Inc. | HKX |
| Oct 31, 1989 | K895575 | BIO-RAD MODULAR AIR COMPRESSOR Bio-Rad | HKX |
| Jan 6, 1989 | K884012 | MMAC II TONOMETER Professional Technologies Corp. | HKX |
| Nov 2, 1987 | K873917 | TONOMETER TAPES Richmond Products, Inc. | HKX |
| Nov 2, 1987 | K873422 | OBF MODEL 115 COMPUTER TONOMETER SYSTEM Ocular Blood Flow Laboratories, Inc. | HKX |
| Jun 3, 1987 | K871935 | T P C (TONOMETER PROBE COVER) Krb Ent. | HKX |
| May 18, 1987 | K871335 | TOPCON COMPUTERIZED TONOMETER CT-10 Topcon Instrument Corporation of America | HKX |
| Mar 17, 1987 | K870750 | KEELER PULSAIR NON CONTACT TONOMETER Keeler Instruments, Inc. | HKX |
| Feb 20, 1987 | K870121 | DIGILAB MICRO ONE APPLANATION TONOMETER Bio-Rad | HKX |
| Feb 12, 1987 | K864959 | OBF MODEL 112 VACUUM CUP SYSTEM Ocular Blood Flow Laboratories, Inc. | HKX |
| Sep 25, 1986 | K863235 | SURGICAL IOP MONITOR Ameritek, Inc. | HKX |
| Sep 24, 1986 | K863217 | DIGILAB MODULAR ONE-APPLANATION TONOMETER Bio-Rad | HKX |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.