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
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 13, 1988
SURGIN EYE SHIELD
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
22d
Cleared
Apr 13, 1988
NANOLAS ND:YAG OPHTHALMIC LASER
LOI
Laser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
7d
Cleared
Apr 04, 1988
MCT 8000 (MULTI-VISION CONTRAST TESTER)
HOX
Chart, Visual Acuity
24d
Cleared
Apr 01, 1988
FRAME, SPECTACLE
HQZ
Frame, Spectacle
185d
Cleared
Apr 01, 1988
ADULT PERCEPTUAL MOTOR PUZZLES (5331-01)
HOX
Chart, Visual Acuity
45d
Cleared
Apr 01, 1988
EASY SHIELD ADHESIVE BANDAGE
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
42d
Cleared
Apr 01, 1988
CALIFORNIA CONVERTIBLES (SUNGLASSES)
HQY
Sunglasses (non-prescription Including Photosensitive)
39d
Cleared
Apr 01, 1988
PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG
HPN
Magnet, Permanent
31d
Cleared
Apr 01, 1988
VCTS 700S SYSTEM
HOX
Chart, Visual Acuity
22d
Cleared
Apr 01, 1988
VCTS MARKETING PROGRAM SYSTEM
HOX
Chart, Visual Acuity
22d
Cleared
Apr 01, 1988
VCTS 6500 SYSTEM
HOX
Chart, Visual Acuity
22d
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 24, 1988
MOBAY (BAYER) MAKROLON 2658 1112
LRX
Case, Contact Lens
185d
Cleared
Mar 24, 1988
GE NORYL 731-80089S
LRX
Case, Contact Lens
185d
Cleared
Mar 24, 1988
MOBAY (BAYER) MERLON M-40 (H)F 1112
LRX
Case, Contact Lens
185d
Cleared
Mar 24, 1988
MOBAY (BAYER) MAKROLON 2658 3291
LRX
Case, Contact Lens
185d
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