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
2900 Ophthalmic devices
Cleared
Apr 13, 1988
PRISMA DISPOSABLE KUGLEN IRRIGATING LENS MANIPULA.
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME
HNY
Cystotome
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE U-SHAPED CANNULA
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE ATKINSON RETROBULBAR NEEDLE
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE ENDO-OCULAR PROBE
HQF
Laser, Ophthalmic
131d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME
HNY
Cystotome
131d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE VISCOELASTIC I/A CANNULA
HMX
Cannula, Ophthalmic
131d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE PUPIL CENTERING CANNULA
HMX
Cannula, Ophthalmic
131d
Cleared
Apr 01, 1988
ADULT PERCEPTUAL MOTOR PUZZLES (5331-01)
HOX
Chart, Visual Acuity
45d
Cleared
Apr 01, 1988
KOI(TM) BLADE GAUGE, MODEL KOI-132
HOE
Caliper, Ophthalmic
17d
Cleared
Mar 30, 1988
MOLTENO VALVE SETON
KYF
Implant, Eye Valve
111d
Cleared
Mar 21, 1988
HEALTH CARE EYE PROTECTION
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
98d
Cleared
Mar 08, 1988
MENTOR B-VAT(TM) II VIDEO TESTER
HOX
Chart, Visual Acuity
84d
Cleared
Mar 07, 1988
DISPOSABLE INFUSION CANNULA 0045-1/2/3 2.5/4.0/6.0
HMX
Cannula, Ophthalmic
167d
Cleared
Feb 26, 1988
HOSKINS-BARKAN GONIOTOMY LENS 10MM
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
58d
Cleared
Feb 26, 1988
BICONCAVE VITRECTOMY LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
58d
Cleared
Feb 19, 1988
PEYMAN G. 12.12 YAG LASER LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
72d
Cleared
Feb 19, 1988
HOSKINS-BARKAN GONIOTOMY LENS 9MM
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
67d
Cleared
Feb 05, 1988
ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPS
HNR
Forceps, Ophthalmic
15d
Cleared
Jan 29, 1988
KEELER ACU 22XT OPHTHALMIC CRYO UNIT
HPS
Unit, Cryophthalmic
86d
Cleared
Jan 27, 1988
ZEISS 40 SL/P PHOTO SLIT LAMP
HJO
Biomicroscope, Slit-lamp, Ac-powered
106d
Cleared
Jan 22, 1988
BIO-COR II COLLAGEN CORNEAL SHIELD
MOE
Collagen Corneal Shield
98d
Cleared
Jan 22, 1988
BIO-COR EXT COLLAGEN CORNEAL SHIELD
MOE
Collagen Corneal Shield
98d
Cleared
Jan 06, 1988
ZEISS VISULAS ARGON LASER
HQF
Laser, Ophthalmic
58d
Cleared
Jan 04, 1988
VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF
HQO
Unit, Cautery, Thermal, Ac-powered
73d
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