Optical Micro Systems, Inc.
Medical device manufacturer in North Andover, MA.
21510(k) clearances
0PMA approvals
0recalls
Device types
- HQE Instrument, Vitreous Aspiration And… 6
- HQC Unit, Phacofragmentation 4
- KYG Device, Irrigation, Ocular Surgery 2
- HKP Instrument, Vitreous Aspiration And… 1
- FMI Needle, Hypodermic, Single Lumen 1
- HMX Cannula, Ophthalmic 1
- HJI Lens, Fundus, Hruby, Diagnostic 1
- HRJ Table, Instrument, Powered, Ophthalmic 1
- LWL Fluid, Intraocular 1
- HNM Needle, Ophthalmic Suturing 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K950218 | Oms Slimline Phaco HandpieceHQC · Traditional | 07/17/1995SE |
| K946054 | DiplomaxHQC · Traditional | 07/11/1995SE |
| K935223 | Ophthalmic Surgical SystemHQC · Traditional | 03/14/1994SE |
| K935226 | I/V PoleKYG · Traditional | 02/16/1994SE |
| K935003 | Electric I/V Pole or EIVP2KYG · Traditional | 01/25/1994SE |
| K870068 | Aspiration Reversal Control (Arc) ModuleHQE · Traditional | 02/12/1987SE |
| K844373 | O.M.S. Ultra-PhacoHQC · Traditional | 12/19/1985SE |
| K844448 | Oms/Gonvers Retinal PerforatorHNM · Traditional | 08/21/1985SE |
| K844895 | Oms Silicone Oil InjectorLWL · Traditional | 06/24/1985SE |
| K844467 | Oms Cryo · Traditional | 02/22/1985SE |
| K844715 | Visc-X Vitreous Aspirating & Cutting Instrument SyHQE · Traditional | 01/22/1985SE |
| K844510 | Oms ScissorsHQE · Traditional | 12/11/1984SE |
| K844374 | O.M.S. Guillotine CutterHQE · Traditional | 12/11/1984SE |
| K833820 | Machemer/Tano RotatingHRJ · Traditional | 01/04/1984SE |
| K820223 | Oms Quartz Infusion Contact LensHJI · Traditional | 02/05/1982SE |
| K813274 | Blood Pool & Subvetinal Fluid AspiratorHQE · Traditional | 02/05/1982SE |
| K813500 | Oms Infusion-Aspiration HandleHQE · Traditional | 02/04/1982SE |
| K813483 | Oms Anterior Chamber Infusion Needle · Traditional | 01/22/1982SE |
| K813481 | Oms Infusion Cannula AssembleHMX · Traditional | 01/22/1982SE |
| K813545 | Hyposermic NeedlesFMI · Traditional | 01/12/1982SE |
| K813273 | Emergency Power Pac (Empac)HKP · Traditional | 12/31/1981SE |