Medical Device Manufacturer · US , Mchenry , IL

Optical Micro Systems, Inc.

21 submissions · 21 cleared · Since 1981
21
Total
21
Cleared
0
Denied

Optical Micro Systems, Inc. — FDA 510(k) Submissions

Optical Micro Systems, Inc. has submitted 21 FDA 510(k) premarket notifications since 1981, of which 21 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Instrument, Vitreous Aspiration And Cutting, Ac-powered, Unit, Phacofragmentation, Device, Irrigation, Ocular Surgery, Table, Instrument, Powered, Ophthalmic, Needle, Ophthalmic Suturing . Use the specialty filter in the sidebar to narrow results.

21 devices
1–21 of 21
OMS SLIMLINE PHACO HANDPIECE
K950218 · HQC Unit, Phacofragmentation · Ophthalmic
Jul 1995 179d
DIPLOMAX
K946054 · HQC Unit, Phacofragmentation · Ophthalmic
Jul 1995 211d
OPHTHALMIC SURGICAL SYSTEM
K935223 · HQC Unit, Phacofragmentation · Ophthalmic
Mar 1994 133d
I/V POLE
K935226 · KYG Device, Irrigation,... · Ophthalmic
Feb 1994 107d
ELECTRIC I/V POLE OR EIVP2
K935003 · KYG Device, Irrigation,... · Ophthalmic
Jan 1994 98d
ASPIRATION REVERSAL CONTROL (ARC) MODULE
K870068 · HQE Instrument, Vitreous... · Ophthalmic
Feb 1987 35d
O.M.S. ULTRA-PHACO
K844373 · HQC Unit, Phacofragmentation · Ophthalmic
Dec 1985 401d
OMS/GONVERS RETINAL PERFORATOR
K844448 · HNM Needle, Ophthalmic Suturing · Ophthalmic
Aug 1985 278d
OMS SILICONE OIL INJECTOR
K844895 · LWL Fluid, Intraocular · Ophthalmic
Jun 1985 189d
OMS CRYO
K844467 · Dental
Feb 1985 95d
VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY
K844715 · HQE Instrument, Vitreous... · Ophthalmic
Jan 1985 56d
O.M.S. GUILLOTINE CUTTER
K844374 · HQE Instrument, Vitreous... · Ophthalmic
Dec 1984 28d
OMS SCISSORS
K844510 · HQE Instrument, Vitreous... · Ophthalmic
Dec 1984 21d
MACHEMER/TANO ROTATING
K833820 · HRJ Table, Instrument,... · Ophthalmic
Jan 1984 63d
BLOOD POOL & SUBVETINAL FLUID ASPIRATOR
K813274 · HQE Instrument, Vitreous... · Ophthalmic
Feb 1982 74d
OMS QUARTZ INFUSION CONTACT LENS
K820223 · HJI Lens, Fundus, Hruby,... · Ophthalmic
Feb 1982 9d
OMS INFUSION-ASPIRATION HANDLE
K813500 · HQE Instrument, Vitreous... · Ophthalmic
Feb 1982 52d
OMS INFUSION CANNULA ASSEMBLE
K813481 · HMX Cannula, Ophthalmic · Ophthalmic
Jan 1982 52d
OMS ANTERIOR CHAMBER INFUSION NEEDLE
K813483 · Ophthalmic
Jan 1982 52d
HYPOSERMIC NEEDLES
K813545 · FMI Needle, Hypodermic,... · General Hospital
Jan 1982 22d
EMERGENCY POWER PAC (EMPAC)
K813273 · HKP Instrument, Vitreous... · Ophthalmic
Dec 1981 41d
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