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 PEARCE IRRIGATING VECTUS
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOS. BISHOP-HARMON IRRIGATING CANNULA
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE SIMCOE I/A CANNULA
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE SIMCOE CAPSULE POLISHER
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME
HNY
Cystotome
133d
Cleared
Apr 13, 1988
PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME
HNY
Cystotome
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE DOUBLE I/A CANNULA CLOSED
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOSA. RYCROFT ANTERIOR CHAMBER CANNULA
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE MVR/STILETTO BLADE
HNN
Knife, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE LEWICKY CHAMBER MAINTAINER
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE J-SHAPED I/A CANNULA
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE SIMCOE EXTRACTOR
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME
HNY
Cystotome
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE MICRO IRRIGATING VECTUS
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE CAPSULE POLISHER
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE RETROBULBAR NEEDLE
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE DOUBLE I/A CANNULA
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOS. PEARCE IRRIGATING VECTUS W/ONE PORT
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE ADAPTER FOR IRRIGATORS
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE SILICONE BULB
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE IRRIGATING IRIS HOOK
HNQ
Hook, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE IRRIGATING LENS DIALER
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME
HNY
Cystotome
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE ANGLED I/A CANNULA
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOS. CURVED LACHRYMAL CANNULA
HMX
Cannula, Ophthalmic
133d
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