FDA Review Panel · OP

FDA 510(k) Ophthalmic Devices

FDA 510(k) Ophthalmic Devices - Regulatory Overview

FDA 510(k) ophthalmic devices include diagnostic and surgical equipment for eye care. The FDA review panel code is OP.

Main categories:

Contact lenses - daily, extended wear, toric and multifocal lenses
Intraocular lenses (IOLs) - monofocal, toric and premium IOLs for cataract surgery
Ophthalmic lasers - excimer lasers for LASIK, Nd:YAG, photocoagulation
Retinal imaging systems - OCT, fundus cameras, fluorescein angiography
Diagnostic instruments - tonometers, perimeters, autorefractors, slit lamps

5110

Total

5092

Cleared

168d

Avg (2y)

1976

Since

2911 Ophthalmic devices

2876–2900 of 2911

Cleared Feb 17, 1977

K770222 · Concept, Inc.

HNI · Retractor, Ophthalmic · 14d

Cleared Feb 14, 1977

NASO-LACRIMAL DUCT INSERT

K770194 · Concept, Inc.

HNL · Probe, Lachrymal · 14d

Cleared Jan 25, 1977

SHEPARD LENS FORCEP W/ IRRIGATOR & LOCK

K770101 · Edward Weck, Inc.

HNR · Forceps, Ophthalmic · 8d

Cleared Jan 25, 1977

HOOK, IRIS, SHEPARD U-SHAPED

K770103 · Edward Weck, Inc.

HNQ · Hook, Ophthalmic · 8d

Cleared Jan 25, 1977

SHEPARD II, LENS FORCEP W/ LOCK

K770105 · Edward Weck, Inc.

HNR · Forceps, Ophthalmic · 8d

Cleared Jan 24, 1977

HERSHMAN LENS FORCEPS WITH IRRIGATOR

K770097 · Edward Weck, Inc.

HNR · Forceps, Ophthalmic · 7d

Cleared Jan 24, 1977

HOOK, IRIS, HERSHMAN

K770098 · Edward Weck, Inc.

HNQ · Hook, Ophthalmic · 7d

Cleared Jan 24, 1977

SHEPARD LENS FORCEP W/ IRRIGA W/OUT LOCK

K770099 · Edward Weck, Inc.

HNR · Forceps, Ophthalmic · 7d

Cleared Jan 24, 1977

BINKHORST LENS FORCEP W/ IRRIGATOR

K770100 · Edward Weck, Inc.

HNR · Forceps, Ophthalmic · 7d

Cleared Jan 24, 1977

HERSHMAN LENS FORCEPS W/OUT IRRIGATOR

K770102 · Edward Weck, Inc.

HNR · Forceps, Ophthalmic · 7d

Cleared Jan 24, 1977

BINKHORST LENS FORCEPS W/OUT IRRIGATOR

K770104 · Edward Weck, Inc.

HNR · Forceps, Ophthalmic · 7d

Cleared Jan 14, 1977

SCISSORS, STRABIMUS, 4 STRAIGHT

K770040 · J. Sklar Mfg. Co., Inc.

HNF · Scissors, Ophthalmic · 4d

Cleared Jan 14, 1977

SCISSORS, STRABISMUS, 4 CURVED

K770041 · J. Sklar Mfg. Co., Inc.

HNF · Scissors, Ophthalmic · 4d

Cleared Jan 12, 1977

K770019 · J. Sklar Mfg. Co., Inc.

HNF · Scissors, Ophthalmic · 7d

Cleared Jan 05, 1977

VITEROUS SUCTION CUTTER

K761353 · Concept, Inc.

HKP · Instrument, Vitreous Aspiration And Cutting, Battery-powered · 8d

Cleared Dec 16, 1976

AD7 PLASTIC MULTIFOCAL EYEGLASS LENS

K761163 · American Optical Corp.

HQG · Lens, Spectacle, Non-custom (prescription) · 15d

Cleared Dec 16, 1976

WECK TYING FORCEP, STRAIGHT TITANIUM

K761251 · Edward Weck, Inc.

HNR · Forceps, Ophthalmic · 3d

Cleared Dec 16, 1976

WECK TYING FORCEP, CURVED TITANIUM

K761252 · Edward Weck, Inc.

HNR · Forceps, Ophthalmic · 3d

Cleared Dec 16, 1976

CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM

K761253 · Edward Weck, Inc.

HND · Spatula, Ophthalmic · 3d

Cleared Nov 11, 1976

CHARLES IRRIGATING FUNDUS CONTACT LENS

K760949 · Richard'S Medical Equip., Inc.

HJI · Lens, Fundus, Hruby, Diagnostic · 10d

Cleared Nov 02, 1976

EVANS ARM AND HAND REST

K760697 · Alcon Laboratories

HRK · Table, Instrument, Manual, Ophthalmic · 41d

Cleared Nov 02, 1976

FELDSTEIN BLEPHAROPLASTY CLIP SHARP P

K760847 · V. Mueller O.V. Baxter Healthcare Corp.

HNC · Specula, Ophthalmic · 18d

Cleared Nov 02, 1976

FELDSTEIN BLEPHAROPLASTY CLIP RECTANGU

K760848 · V. Mueller O.V. Baxter Healthcare Corp.

HNC · Specula, Ophthalmic · 18d

Cleared Nov 02, 1976

FELDSTEIN BLEPHAROSTOMY CLIP SQUARE

K760849 · V. Mueller O.V. Baxter Healthcare Corp.

HNC · Specula, Ophthalmic · 18d

Cleared Oct 15, 1976

SOLA COMMIDO LOUPE

K760770 · Codman & Shurtleff, Inc.

HLJ · Ophthalmoscope, Battery-powered · 11d

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