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
Nov 03, 2004
AQUIFY LENS COMFORT DROPS
LPN
Accessories, Soft Lens Products
84d
Cleared
Oct 28, 2004
KARATS MULTIPURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
511d
Cleared
Oct 28, 2004
VISTAKON (SENOFILCON A) SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
66d
Cleared
Oct 28, 2004
CENTURION SES EPIKERATOME
HNO
Keratome, Ac-powered
16d
Cleared
Oct 26, 2004
COOPER PROSTHETIC
LPL
Lenses, Soft Contact, Daily Wear
48d
Cleared
Oct 19, 2004
COMPLETE BLINK-N-CLEAN LENS DROPS
MRC
Products, Contact Lens Care, Rigid Gas Permeable
202d
Cleared
Oct 13, 2004
MB 105 MILLENNIUM BLADES
HNO
Keratome, Ac-powered
168d
Cleared
Oct 13, 2004
HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)
MXK
Device, Analysis, Anterior Segment
9d
Cleared
Oct 08, 2004
THE FUGO BLADE FOR GLAUCOMA
NCR
Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-powered
171d
Cleared
Oct 07, 2004
PANORAMIC 200A
HLI
Ophthalmoscope, Ac-powered
73d
Cleared
Oct 06, 2004
LASEREX, MODEL LP4532
HQF
Laser, Ophthalmic
114d
Cleared
Sep 20, 2004
IRIS MEDICAL IQ 810 PHOTOCOAGULATOR
HQF
Laser, Ophthalmic
234d
Cleared
Sep 16, 2004
ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
307d
Cleared
Sep 15, 2004
EPITOME SYSTEM
HNO
Keratome, Ac-powered
131d
Cleared
Sep 15, 2004
ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
27d
Cleared
Sep 02, 2004
PATHFINDER
MXK
Device, Analysis, Anterior Segment
450d
Cleared
Aug 30, 2004
CARRIAZO PENDULAR
HNO
Keratome, Ac-powered
343d
Cleared
Aug 16, 2004
PHACO CHOP NEEDLES
HQC
Unit, Phacofragmentation
21d
Cleared
Jul 30, 2004
SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
252d
Cleared
Jul 30, 2004
CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
38d
Cleared
Jul 23, 2004
NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)
MXK
Device, Analysis, Anterior Segment
106d
Cleared
Jul 23, 2004
LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS
LPL
Lenses, Soft Contact, Daily Wear
84d
Cleared
Jul 16, 2004
MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM
HPZ
Implant, Eye Sphere
107d
Cleared
Jul 13, 2004
INTELIPORT OCCLUDING DEVICE
LZU
Plug, Punctum
162d
Cleared
Jul 07, 2004
C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
22d
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