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
Mar 25, 1997
HEDGES CORNEAL WETTING PAK
KYG
Device, Irrigation, Ocular Surgery
70d
Cleared
Mar 25, 1997
VICTORY EYEWEAR CO
HQY
Sunglasses (non-prescription Including Photosensitive)
41d
Cleared
Mar 19, 1997
SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE
HLI
Ophthalmoscope, Ac-powered
706d
Cleared
Mar 19, 1997
AARON VAC 2
HKP
Instrument, Vitreous Aspiration And Cutting, Battery-powered
656d
Cleared
Mar 19, 1997
DAKOTA SMITH, NICOLE MILLER SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
86d
Cleared
Mar 19, 1997
PROMED 55-G SOFT DAILY WEAR CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
29d
Cleared
Mar 17, 1997
DGH MODEL 9000
HQC
Unit, Phacofragmentation
84d
Cleared
Mar 11, 1997
LIFESTYLE 4-VUE (POLYMACON) HYDROPHILIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
221d
Cleared
Mar 11, 1997
CONTACT LENSES METRO-G 3X (HIOXIFILCON B)
LPL
Lenses, Soft Contact, Daily Wear
95d
Cleared
Mar 11, 1997
LIFESTYLE BREAK THRU (POLYMACON)
LPL
Lenses, Soft Contact, Daily Wear
85d
Cleared
Mar 11, 1997
ROCCOBAROCCO & PRO-DYNAMIX
HQY
Sunglasses (non-prescription Including Photosensitive)
77d
Cleared
Mar 07, 1997
(LENSES) BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE TINT
LPL
Lenses, Soft Contact, Daily Wear
115d
Cleared
Mar 04, 1997
EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD
HOZ
Sponge, Ophthalmic
90d
Cleared
Mar 04, 1997
JAMES ALEX SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
50d
Cleared
Mar 03, 1997
CANON TX-10 TONOMETER
HKX
Tonometer, Ac-powered
208d
Cleared
Feb 26, 1997
PHACOILLUMINATOR - FIBEROPTIC SLEEVE
HQC
Unit, Phacofragmentation
142d
Cleared
Feb 25, 1997
SUNGLASSES (NON-PRESCRIPTION)
HQY
Sunglasses (non-prescription Including Photosensitive)
77d
Cleared
Feb 25, 1997
NON-PRESCRIPTION SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
71d
Cleared
Feb 21, 1997
CERALAS DIODE LASER SYSTEM (CERALAS D2)
HQF
Laser, Ophthalmic
87d
Cleared
Feb 20, 1997
SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
90d
Cleared
Feb 18, 1997
BAERVELT PARS PLANA GLAUCOMA IMPLANT
KYF
Implant, Eye Valve
447d
Cleared
Feb 03, 1997
RTA RETINAL THICKNESS ANALYZER
HLI
Ophthalmoscope, Ac-powered
111d
Cleared
Feb 03, 1997
STORZ E8010 ERGOTEC/PREMIERE ADAPTOR
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
69d
Cleared
Jan 30, 1997
SPECIALTY T TORIC (OCUFILCON A) CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
133d
Cleared
Jan 30, 1997
VISTAKON (GENFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILIITY TINT
LPL
Lenses, Soft Contact, Daily Wear
73d
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