Company ยท US
Tomey Corporation USA
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2025. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 |
| OBO | Tomography, Optical Coherence | 2 |
| GWE | Stimulator, Photic, Evoked Response | 1 |
| HKI | Camera, Ophthalmic, Ac-Powered | 1 |
| HKO | Refractometer, Ophthalmic | 1 |
| HKX | Tonometer, Ac-Powered | 1 |
| HKY | Tonometer, Manual | 1 |
| HLT | Preamplifier, Ac-Powered, Ophthalmic | 1 |
| HLZ | Electrode, Corneal | 1 |
| LQJ | Lens, Surgical, Laser, Accesssory, Ophthalmic Laser | 1 |
| MXK | Device, Analysis, Anterior Segment | 1 |
| NQE | Microscope, Specular | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 18, 2025 | K252348 | Tomey Optical Biometer OA-2000 (OA-2000) Tomey Corporation, JP | MXK |
| Jul 18, 2025 | K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2) Tomey Corporation, JP | OBO |
| Apr 27, 2022 | K213265 | Tomey Cornea/Anterior Segment OCT CASIA2 Tomey Corporation, JP | OBO |
| Jan 19, 2018 | K171313 | EM-4000 Specular Microscope Tomey Corporation, JP | NQE |
| Nov 18, 2008 | K073087 | NON-CONTACT TONOMETER, MODEL FT-1000 Tomey Corporation, JP | HKX |
| Apr 10, 2002 | K020151 | UD-1000 ULTRASONIC A/B SCANNER Tomey Corp. USA | IYO |
| Apr 8, 2002 | K012803 | AL-2000 COMBINED BIOMETER AND PACHYMETER Tomey Corp. | IYO |
| Aug 14, 1997 | K971953 | CONFOSCAN Tomey Corporation USA | HJO |
| Jun 24, 1997 | K971685 | IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM Tomey Corporation USA | HKI |
| May 9, 1997 | K961805 | TOMEY DTL ELECTRODE Tomey Corporation USA | HLZ |
| Aug 31, 1995 | K932571 | TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 Tomey Corporation USA | GWE |
| Mar 1, 1995 | K945959 | VIDEO VISION ANALYZER (VIVA), VRB 100 Tomey Corporation USA | HKO |
| Nov 22, 1994 | K944910 | TOMEY EM-1000 SPECULAR MICROSCOPE Tomey Corporation USA | HJO |
| Apr 5, 1993 | K924760 | TOMEY PROTON TONOMETER Tomey Corporation USA | HKY |
| Jul 15, 1992 | K921815 | TOMEY PE-300 PORTABLE ERG Tomey Corporation USA | HLT |
| Jun 17, 1991 | K912112 | PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 Tomey Corporation USA | LQJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||