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
May 26, 1988
MICROLINE CAT #100
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
80d
Cleared
May 25, 1988
NIDEK CV-4000
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
82d
Cleared
May 25, 1988
SPECTACLE, FRAME AND SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
61d
Cleared
May 25, 1988
PLASTIC FRAME & LENS SUNGLASS
HQY
Sunglasses (non-prescription Including Photosensitive)
51d
Cleared
May 25, 1988
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
43d
Cleared
May 25, 1988
PRISMA TECH 19 GAUGE DISPOSABLE EXTRUSION NEEDLES
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
16d
Cleared
May 23, 1988
TEAR VOLUME TESTS
KYD
Strip, Schirmer
42d
Cleared
May 13, 1988
PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS
LXP
Plug, Scleral
67d
Cleared
May 13, 1988
ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG
LXP
Plug, Scleral
67d
Cleared
May 13, 1988
MENTOR WET-FIELD*II COAGULATOR
HQQ
Apparatus, Cautery, Radiofrequency, Battery-powered
65d
Cleared
May 13, 1988
ADVANCE DIAGNOSTICS DISPOSABLE EYECUP
LXQ
Cup, Eye
42d
Cleared
May 13, 1988
MVR/STILETTO BLADE 20GA. - P/N 1900
HNN
Knife, Ophthalmic
25d
Cleared
May 03, 1988
ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY
HPX
Lens, Contact (polymethylmethacrylate)
176d
Cleared
May 03, 1988
OCU-1
HMX
Cannula, Ophthalmic
148d
Cleared
May 03, 1988
CYSTOTOMES/KNIFES
HNY
Cystotome
98d
Cleared
May 03, 1988
CANNULAS
HMX
Cannula, Ophthalmic
98d
Cleared
May 03, 1988
ANESTHESIA/RETROBULBAR NEEDLES
HMX
Cannula, Ophthalmic
98d
Cleared
May 03, 1988
BLUE PLASTIC EYE SHIELD
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
89d
Cleared
May 03, 1988
AUTOMATIC PERIMETER, AP-340
HPT
Perimeter, Automatic, Ac-powered
42d
Cleared
Apr 29, 1988
OPHTHALMIC CANNULA
HMX
Cannula, Ophthalmic
21d
Cleared
Apr 19, 1988
MODEL 2001 PHACOEMULSIFIER ASPIRATOR
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
42d
Cleared
Apr 19, 1988
OPHTHALMIC SPECTACLE LENS BLANKS
HQG
Lens, Spectacle, Non-custom (prescription)
28d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE GILLS ANGLED I/A CANNULA
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE KRATZ CAPSULE POLISHER
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOS. TROUTMAN ALPHA-CHYMOTRYPSIN CANNULA
HMX
Cannula, Ophthalmic
133d
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