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
Dec 23, 1992
INFINITY MICRO IRRIGATOR
KYG
Device, Irrigation, Ocular Surgery
133d
Cleared
Dec 23, 1992
AMO ELITE
HQC
Unit, Phacofragmentation
121d
Cleared
Dec 15, 1992
BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE
HMJ
Screen, Tangent, Projection, Battery-powered
84d
Cleared
Dec 10, 1992
OPHTHALMIC KNIFE
HNN
Knife, Ophthalmic
204d
Cleared
Nov 27, 1992
STORZ REUS 20/25 GAUGE VITRE CUT W/REUS HAND/DRIV
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
77d
Cleared
Nov 23, 1992
SUNGLASSES, NON PRESCRIPTION
HQY
Sunglasses (non-prescription Including Photosensitive)
283d
Cleared
Nov 23, 1992
MODIFIED SITE FIBER OPTIC MODULE
FCT
Headlight, Fiberoptic Focusing
95d
Cleared
Nov 16, 1992
TROKEL /3 GONIO LASER LENS
LQJ
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
237d
Cleared
Nov 16, 1992
BYRNE EXPULSIVE LENS
HJI
Lens, Fundus, Hruby, Diagnostic
117d
Cleared
Nov 05, 1992
LENSONIC(TM) CONTACT LENS CARE ACCESSORY
LYL
Accessories, Solution, Ultrasonic Cleaners For Lenses
213d
Cleared
Nov 05, 1992
ALTEX MODEL UST-3000E
HQC
Unit, Phacofragmentation
86d
Cleared
Nov 05, 1992
SPECTACLE FRAMES
HQZ
Frame, Spectacle
73d
Cleared
Oct 28, 1992
BOSTON CLEANER II
LPN
Accessories, Soft Lens Products
107d
Cleared
Oct 27, 1992
REGALTECH MAXISCOPE
HLI
Ophthalmoscope, Ac-powered
230d
Cleared
Oct 19, 1992
OPHTHALMIC TRICHIASIS PROBE
HPS
Unit, Cryophthalmic
90d
Cleared
Oct 13, 1992
DBA FOCAL CHANGE FRAMES
HQZ
Frame, Spectacle
95d
Cleared
Oct 06, 1992
OPTISOL-GS CORNEAL STORAGE MEDIA
LYX
Media, Corneal Storage
48d
Cleared
Oct 02, 1992
COMPUTERIZED PUPIL
HLG
Pupillometer, Ac-powered
218d
Cleared
Sep 30, 1992
910T MONTORIZED INSTRUMENT TABLE
HRJ
Table, Instrument, Powered, Ophthalmic
140d
Cleared
Sep 30, 1992
MEDICAL BATTERY PACKS
HLJ
Ophthalmoscope, Battery-powered
224d
Cleared
Sep 30, 1992
TONOSHIELD TONOMETER SHIELD
HKY
Tonometer, Manual
58d
Cleared
Sep 17, 1992
OPTICAL FRAMES
HQZ
Frame, Spectacle
92d
Cleared
Sep 02, 1992
VISOR SUNGLASSES/LENS/NOVELTY VISOR
HQY
Sunglasses (non-prescription Including Photosensitive)
287d
Cleared
Sep 02, 1992
SOLAZ
HQY
Sunglasses (non-prescription Including Photosensitive)
148d
Cleared
Sep 02, 1992
SPECTACLE FRAMES
HQZ
Frame, Spectacle
119d
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