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
2894 Ophthalmic devices
Cleared
Nov 25, 1996
SPENSER SUNGLASSES AND SPORT SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
47d
Cleared
Nov 25, 1996
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
45d
Cleared
Nov 25, 1996
SUNGLASSES(NON-PRESCRIPTION)
HQY
Sunglasses (non-prescription Including Photosensitive)
55d
Cleared
Nov 20, 1996
METRO FOCAL ASPHERIC (POLYMACON)
LPL
Lenses, Soft Contact, Daily Wear
209d
Cleared
Nov 20, 1996
LIFESTYLE GP (TELEFOCON B) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENS FOR DAILY WEAR
HQD
Lens, Contact (other Material) - Daily
110d
Cleared
Nov 20, 1996
SPECIALTY PROGRESSIVE(METHAFILCON A)MULTIFOCAL SOFT(HYDROPHILIC)CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED)
LPL
Lenses, Soft Contact, Daily Wear
78d
Cleared
Nov 19, 1996
VARIOUS SUNGLASSES (NON-PRESCRIPTION)
HQY
Sunglasses (non-prescription Including Photosensitive)
54d
Cleared
Nov 19, 1996
DR. BERT'S SUNCARE PRODUCTS PEEPER KEEPERS
HQY
Sunglasses (non-prescription Including Photosensitive)
48d
Cleared
Nov 19, 1996
FLYWAY
HQY
Sunglasses (non-prescription Including Photosensitive)
47d
Cleared
Nov 05, 1996
HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM
HQC
Unit, Phacofragmentation
288d
Cleared
Oct 28, 1996
RETINAL DETACHMENT IMPLANTS
HQX
Implant, Orbital, Extra-ocular
73d
Cleared
Oct 22, 1996
OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)
HKI
Camera, Ophthalmic, Ac-powered
60d
Cleared
Oct 18, 1996
C.O.L.D.A.
HQY
Sunglasses (non-prescription Including Photosensitive)
37d
Cleared
Oct 09, 1996
MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
140d
Cleared
Oct 02, 1996
PHACOSCOPE
HQC
Unit, Phacofragmentation
218d
Cleared
Oct 01, 1996
PRECISION UV (VASURFILCON A)
LPL
Lenses, Soft Contact, Daily Wear
180d
Cleared
Oct 01, 1996
FLEXLENS
LPL
Lenses, Soft Contact, Daily Wear
134d
Cleared
Oct 01, 1996
FLEXLENS(METHAFILCON A)
LPL
Lenses, Soft Contact, Daily Wear
132d
Cleared
Oct 01, 1996
ACUVUE (ETAFILCON A) CONTACT LENS CLEAR & W/VISIBILITY TINT W/UV BLOCKER
LPL
Lenses, Soft Contact, Daily Wear
75d
Cleared
Oct 01, 1996
RURASOFT 2 FRESHLOOK COLORS
LPL
Lenses, Soft Contact, Daily Wear
63d
Cleared
Sep 20, 1996
STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH
HQC
Unit, Phacofragmentation
262d
Cleared
Sep 19, 1996
AMO PRESTIGE DAY PACK (ALLERGAN, INC.)
HQC
Unit, Phacofragmentation
90d
Cleared
Sep 18, 1996
STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
258d
Cleared
Sep 18, 1996
RYDER LACRIMAL INTUBATIONSET
OKS
Lacrimal Stents And Intubation Sets
106d
Cleared
Sep 05, 1996
GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
87d
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