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

5119

Total

5101

Cleared

169d

Avg (2y)

1976

Since

5119 Ophthalmic devices

4201–4225 of 5119

Cleared Apr 21, 1986

AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE

K860891 · Intra-Optics Labs. C/O Newman Assoc.

HQE · Instrument, Vitreous Aspiration And Cutting, Ac-powered · 42d

Cleared Apr 15, 1986

PHOTRON VISUAL FIELD ANALYZER

K860642 · Biosan Laboratories, Inc.

HOM · Screen, Tangent, Ac-powered (campimeter) · 54d

Cleared Apr 15, 1986

STORZ/MAZZACCO LENS FORCEP

K860915 · Storz Instrument Co.

HNR · Forceps, Ophthalmic · 35d

Cleared Apr 15, 1986

LM-850 AUTOMATIC LENSMETER

K861064 · Nidek, Inc.

HLM · Instrument, Measuring, Lens, Ac-powered · 26d

Cleared Apr 09, 1986

AR-1100 AUTOMATIC REFRACTOR

K861065 · Nidek, Inc.

HKO · Refractometer, Ophthalmic · 20d

Cleared Apr 04, 1986

BAUSCH & LOMB LENS CARRYING CASE

K854968 · Bausch & Lomb, Inc.

HPX · Lens, Contact (polymethylmethacrylate) · 114d

Cleared Apr 04, 1986

GUNKEL CHROMAGRAPH COLOR VISION TESTER

K860174 · Chromagraphics, Inc.

HIW · Anomaloscope · 77d

Cleared Apr 04, 1986

BACSTOP FILTER IRRIGATION SUPPLY KIT

K860544 · Staar Surgical Co.

KYG · Device, Irrigation, Ocular Surgery · 50d

Cleared Apr 04, 1986

K860928 · Indivisual Corporation, Inc.

Cleared Apr 04, 1986

SUPERLITE PENLIGHT

K861028 · Keta Corp.

Cleared Apr 04, 1986

AR-1600 AUTOMATIC REFRACTOR

K861062 · Nidek, Inc.

HKO · Refractometer, Ophthalmic · 15d

Cleared Apr 04, 1986

NIDEK KM-800 AUTO KERATOMETER

K861063 · Nidek, Inc.

HLQ · Keratoscope, Ac-powered · 15d

Cleared Apr 04, 1986

AR-1000 AUTOMATIC REFRACTOR

K861066 · Nidek, Inc.

HKO · Refractometer, Ophthalmic · 15d

Cleared Mar 31, 1986

K855105 · Mira, Inc.

HQT · Shell, Scleral · 98d

Cleared Mar 31, 1986

OPTHALMIC SURGICAL INSTRUMENTS

K860744 · Tridak Division of Indicon, Inc.

HMX · Cannula, Ophthalmic · 32d

Cleared Mar 31, 1986

SPECTACLES FRAME

K860954 · Roseburg SA

HQZ · Frame, Spectacle · 18d

Cleared Mar 31, 1986

SPECTACLES LENS

K860955 · Roseburg SA

HQG · Lens, Spectacle, Non-custom (prescription) · 18d

Cleared Mar 31, 1986

RARE EARTH INTRA-OCULAR MAGNET

K860960 · Ameritek, Inc.

HPN · Magnet, Permanent · 18d

Cleared Mar 31, 1986

ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)

K861013 · Ameritek, Inc.

KYG · Device, Irrigation, Ocular Surgery · 13d

Cleared Mar 28, 1986

SAPPHIRE BLADE SURGICAL KNIFE

K860852 · Med-Tech Develoment Corp.

HNN · Knife, Ophthalmic · 21d

Cleared Mar 25, 1986

BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA

K860648 · Precision Instruments, Inc.

HRH · Trephine, Manual, Ophthalmic · 33d

Cleared Mar 21, 1986

MAZZOCCO/FRENCHIK FOLDER

K860148 · Staar Surgical Co.

KYB · Lens, Guide, Intraocular · 65d

Cleared Mar 21, 1986

FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE)

K860358 · Hgm, Inc.

HQF · Laser, Ophthalmic · 50d

Cleared Mar 11, 1986

HARD CONTACT LENS CLEANING & SOAKING SOLUTION

K853808 · Maurry Biological Co.

HPX · Lens, Contact (polymethylmethacrylate) · 181d

Cleared Mar 11, 1986

DAILY HARD CONTACT LENS CLEANER

K853809 · Maurry Biological Co.

HPX · Lens, Contact (polymethylmethacrylate) · 181d

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