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

5106
Total
5088
Cleared
170d
Avg (2y)
1976
Since
1303 Ophthalmic devices
926–950 of 1303
Cleared Apr 13, 1988
PRISMA DISPOSABLE ADAPTER FOR IRRIGATORS
K874989 · Advanced Surgical Products, Inc.
HMX · Cannula, Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE SILICONE BULB
K874990 · Advanced Surgical Products, Inc.
HMX · Cannula, Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE IRRIGATING IRIS HOOK
K874991 · Advanced Surgical Products, Inc.
HNQ · Hook, Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE IRRIGATING LENS DIALER
K874992 · Advanced Surgical Products, Inc.
HMX · Cannula, Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME
K874993 · Advanced Surgical Products, Inc.
HNY · Cystotome · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE ANGLED I/A CANNULA
K874994 · Advanced Surgical Products, Inc.
HMX · Cannula, Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOS. CURVED LACHRYMAL CANNULA
K874995 · Advanced Surgical Products, Inc.
HMX · Cannula, Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE KUGLEN IRRIGATING LENS MANIPULA.
K874996 · Advanced Surgical Products, Inc.
HMX · Cannula, Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME
K874997 · Advanced Surgical Products, Inc.
HNY · Cystotome · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE U-SHAPED CANNULA
K874998 · Advanced Surgical Products, Inc.
HMX · Cannula, Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE ATKINSON RETROBULBAR NEEDLE
K874999 · Advanced Surgical Products, Inc.
HMX · Cannula, Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE ENDO-OCULAR PROBE
K875000 · Advanced Surgical Products, Inc.
HQF · Laser, Ophthalmic · 131d
Cleared Apr 13, 1988
PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME
K875001 · Advanced Surgical Products, Inc.
HNY · Cystotome · 131d
Cleared Apr 13, 1988
PRISMA DISPOSABLE VISCOELASTIC I/A CANNULA
K875002 · Advanced Surgical Products, Inc.
HMX · Cannula, Ophthalmic · 131d
Cleared Apr 13, 1988
PRISMA DISPOSABLE PUPIL CENTERING CANNULA
K875003 · Advanced Surgical Products, Inc.
HMX · Cannula, Ophthalmic · 131d
Cleared Apr 01, 1988
ADULT PERCEPTUAL MOTOR PUZZLES (5331-01)
K880647 · Fred Sammons, Inc.
HOX · Chart, Visual Acuity · 45d
Cleared Apr 01, 1988
KOI(TM) BLADE GAUGE, MODEL KOI-132
K881094 · CooperVision, Inc.
HOE · Caliper, Ophthalmic · 17d
Cleared Mar 21, 1988
HEALTH CARE EYE PROTECTION
K875107 · Surgikos, Inc.
HOY · Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) · 98d
Cleared Mar 07, 1988
DISPOSABLE INFUSION CANNULA 0045-1/2/3 2.5/4.0/6.0
K873853 · Advanced Surgical Products, Inc.
HMX · Cannula, Ophthalmic · 167d
Cleared Feb 26, 1988
HOSKINS-BARKAN GONIOTOMY LENS 10MM
K875330 · Ocular Instruments, Inc.
HJK · Lens, Contact, Polymethylmethacrylate, Diagnostic · 58d
Cleared Feb 26, 1988
BICONCAVE VITRECTOMY LENS
K875331 · Ocular Instruments, Inc.
HJK · Lens, Contact, Polymethylmethacrylate, Diagnostic · 58d
Cleared Feb 19, 1988
PEYMAN G. 12.12 YAG LASER LENS
K875087 · Ocular Instruments, Inc.
HJK · Lens, Contact, Polymethylmethacrylate, Diagnostic · 72d
Cleared Feb 19, 1988
HOSKINS-BARKAN GONIOTOMY LENS 9MM
K875114 · Ocular Instruments, Inc.
HJK · Lens, Contact, Polymethylmethacrylate, Diagnostic · 67d
Cleared Feb 05, 1988
ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPS
K880274 · Advanced Surgical Products, Inc.
HNR · Forceps, Ophthalmic · 15d
Cleared Jan 29, 1988
KEELER ACU 22XT OPHTHALMIC CRYO UNIT
K874555 · Keeler Instruments, Inc.
HPS · Unit, Cryophthalmic · 86d

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All categories 1303 LPL Lenses, Soft Contact, Daily Wear 161 HQC Unit, Phacofragmentation 81 HQF Laser, Ophthalmic 64 HKI Camera, Ophthalmic, Ac-powered 59 LPN Accessories, Soft Lens Products 52 OBO Tomography, Optical Coherence 37 HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered 37 HMX Cannula, Ophthalmic 37 NFJ System, Image Management, Ophthalmic 34 HNR Forceps, Ophthalmic 28 HJK Lens, Contact, Polymethylmethacrylate, Diagnostic 28 HQD Lens, Contact (other Material) - Daily 26 HJO Biomicroscope, Slit-lamp, Ac-powered 25 HKX Tonometer, Ac-powered 23 HNN Knife, Ophthalmic 21