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
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
Cleared
Jan 29, 1997
EAGLE EYES
HQY
Sunglasses (non-prescription Including Photosensitive)
89d
Cleared
Jan 29, 1997
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
76d
Cleared
Jan 29, 1997
SENNA
HQY
Sunglasses (non-prescription Including Photosensitive)
64d
Cleared
Jan 22, 1997
LC-250 INFRARED LIGHT COAGULATOR
HQB
Photocoagulator And Accessories
79d
Cleared
Jan 10, 1997
GIANNI VERSACE SUNGLASSES, VERSUS SUNGLASSES, DIABLO SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
63d
Cleared
Jan 09, 1997
AMOILS EPITHELIAL SCRUBBER
HOG
Burr, Corneal, Battery-powered
161d
Cleared
Jan 09, 1997
EYECHEK
HLQ
Keratoscope, Ac-powered
73d
Cleared
Jan 09, 1997
RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT
HKM
Retinoscope, Battery-powered
70d
Cleared
Dec 23, 1996
CORNEAL TOPOGRAPHER 200
MMQ
Topographer, Corneal, Ac-powered
95d
Cleared
Dec 20, 1996
VITLITE (TR7700)
MPA
Endoilluminator
112d
Cleared
Dec 20, 1996
HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLAN
LPL
Lenses, Soft Contact, Daily Wear
87d
Cleared
Dec 20, 1996
ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING
LYL
Accessories, Solution, Ultrasonic Cleaners For Lenses
59d
Cleared
Dec 20, 1996
PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS
LZU
Plug, Punctum
59d
Cleared
Dec 17, 1996
HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
194d
Cleared
Dec 17, 1996
EYE FIXATION SPECULUM
HNC
Specula, Ophthalmic
50d
Cleared
Dec 17, 1996
PLASTIC SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
49d
Cleared
Dec 12, 1996
SUNGLASSES OR MULTIPLE
HQY
Sunglasses (non-prescription Including Photosensitive)
37d
Cleared
Dec 09, 1996
ML MICROKERATOME BLADE
HNO
Keratome, Ac-powered
154d
Cleared
Nov 29, 1996
NEW COMFORT CONTACT LENS CARE ACCESSORY
LYL
Accessories, Solution, Ultrasonic Cleaners For Lenses
182d
Cleared
Nov 29, 1996
CONTACT LENS WITH COLOR ADDITIVE
LPL
Lenses, Soft Contact, Daily Wear
128d
Cleared
Nov 29, 1996
LIFESTYLE FREQUENCY PROGRESSIVE (METHAFILCON A) MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
119d
Cleared
Nov 27, 1996
DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
85d
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