Optical Micro Systems, Inc.
Mchenry, IL, US
Optical Micro Systems, Inc. appears in FDA device records in Mchenry, IL. FDA records list 21 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for Optical Micro Systems, Inc. between 1981 and 1995. The busiest year on record is 1982, with 6. The most recent is 1995, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1982 | 6 |
| 1984 | 3 |
| 1985 | 5 |
| 1987 | 1 |
| 1994 | 3 |
| 1995 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K950218 | OMS SLIMLINE PHACO HANDPIECE | HQC | Substantially Equivalent | |
| K946054 | DIPLOMAX | HQC | Substantially Equivalent | |
| K935223 | OPHTHALMIC SURGICAL SYSTEM | HQC | Substantially Equivalent | |
| K935226 | I/V POLE | KYG | Substantially Equivalent | |
| K935003 | ELECTRIC I/V POLE OR EIVP2 | KYG | Substantially Equivalent | |
| K870068 | ASPIRATION REVERSAL CONTROL (ARC) MODULE | HQE | Substantially Equivalent | |
| K844373 | O.M.S. ULTRA-PHACO | HQC | Substantially Equivalent | |
| K844448 | OMS/GONVERS RETINAL PERFORATOR | HNM | Substantially Equivalent | |
| K844895 | OMS SILICONE OIL INJECTOR | LWL | Substantially Equivalent | |
| K844467 | OMS CRYO | Substantially Equivalent | ||
| K844715 | VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY | HQE | Substantially Equivalent | |
| K844510 | OMS SCISSORS | HQE | Substantially Equivalent | |
| K844374 | O.M.S. GUILLOTINE CUTTER | HQE | Substantially Equivalent | |
| K833820 | MACHEMER/TANO ROTATING | HRJ | Substantially Equivalent | |
| K820223 | OMS QUARTZ INFUSION CONTACT LENS | HJI | Substantially Equivalent | |
| K813274 | BLOOD POOL & SUBVETINAL FLUID ASPIRATOR | HQE | Substantially Equivalent | |
| K813500 | OMS INFUSION-ASPIRATION HANDLE | HQE | Substantially Equivalent | |
| K813483 | OMS ANTERIOR CHAMBER INFUSION NEEDLE | Substantially Equivalent | ||
| K813481 | OMS INFUSION CANNULA ASSEMBLE | HMX | Substantially Equivalent | |
| K813545 | HYPOSERMIC NEEDLES | FMI | Substantially Equivalent | |
| K813273 | EMERGENCY POWER PAC (EMPAC) | HKP | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- HMXCannula, Ophthalmic
- KYGDevice, Irrigation, Ocular Surgery
- LWLFluid, Intraocular
- HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered
- HKPInstrument, Vitreous Aspiration And Cutting, Battery-Powered
- HJILens, Fundus, Hruby, Diagnostic
- FMINeedle, Hypodermic, Single Lumen
- HNMNeedle, Ophthalmic Suturing
- HRJTable, Instrument, Powered, Ophthalmic
- HQCUnit, Phacofragmentation
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain
