Company ยท US
Optical Micro Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1995. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 6 |
| HQC | Unit, Phacofragmentation | 4 |
| KYG | Device, Irrigation, Ocular Surgery | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 1 |
| HJI | Lens, Fundus, Hruby, Diagnostic | 1 |
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered | 1 |
| HMX | Cannula, Ophthalmic | 1 |
| HNM | Needle, Ophthalmic Suturing | 1 |
| HRJ | Table, Instrument, Powered, Ophthalmic | 1 |
| LWL | Fluid, Intraocular | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 17, 1995 | K950218 | OMS SLIMLINE PHACO HANDPIECE Optical Micro Systems, Inc. | HQC |
| Jul 11, 1995 | K946054 | DIPLOMAX Optical Micro Systems, Inc. | HQC |
| Mar 14, 1994 | K935223 | OPHTHALMIC SURGICAL SYSTEM Optical Micro Systems, Inc. | HQC |
| Feb 16, 1994 | K935226 | I/V POLE Optical Micro Systems, Inc. | KYG |
| Jan 25, 1994 | K935003 | ELECTRIC I/V POLE OR EIVP2 Optical Micro Systems, Inc. | KYG |
| Feb 12, 1987 | K870068 | ASPIRATION REVERSAL CONTROL (ARC) MODULE Optical Micro Systems, Inc. | HQE |
| Dec 19, 1985 | K844373 | O.M.S. ULTRA-PHACO Optical Micro Systems, Inc. | HQC |
| Aug 21, 1985 | K844448 | OMS/GONVERS RETINAL PERFORATOR Optical Micro Systems, Inc. | HNM |
| Jun 24, 1985 | K844895 | OMS SILICONE OIL INJECTOR Optical Micro Systems, Inc. | LWL |
| Feb 22, 1985 | K844467 | OMS CRYO Optical Micro Systems, Inc. | |
| Jan 22, 1985 | K844715 | VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY Optical Micro Systems, Inc. | HQE |
| Dec 11, 1984 | K844510 | OMS SCISSORS Optical Micro Systems, Inc. | HQE |
| Dec 11, 1984 | K844374 | O.M.S. GUILLOTINE CUTTER Optical Micro Systems, Inc. | HQE |
| Jan 4, 1984 | K833820 | MACHEMER/TANO ROTATING Optical Micro Systems, Inc. | HRJ |
| Feb 5, 1982 | K820223 | OMS QUARTZ INFUSION CONTACT LENS Optical Micro Systems, Inc. | HJI |
| Feb 5, 1982 | K813274 | BLOOD POOL & SUBVETINAL FLUID ASPIRATOR Optical Micro Systems, Inc. | HQE |
| Feb 4, 1982 | K813500 | OMS INFUSION-ASPIRATION HANDLE Optical Micro Systems, Inc. | HQE |
| Jan 22, 1982 | K813483 | OMS ANTERIOR CHAMBER INFUSION NEEDLE Optical Micro Systems, Inc. | |
| Jan 22, 1982 | K813481 | OMS INFUSION CANNULA ASSEMBLE Optical Micro Systems, Inc. | HMX |
| Jan 12, 1982 | K813545 | HYPOSERMIC NEEDLES Optical Micro Systems, Inc. | FMI |
| Dec 31, 1981 | K813273 | EMERGENCY POWER PAC (EMPAC) Optical Micro Systems, Inc. | HKP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||