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
2888 Ophthalmic devices
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 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 07, 2004
PANORAMIC 200A
HLI
Ophthalmoscope, Ac-powered
73d
Cleared
Oct 06, 2004
LASEREX, MODEL LP4532
HQF
Laser, Ophthalmic
114d
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
Aug 16, 2004
PHACO CHOP NEEDLES
HQC
Unit, Phacofragmentation
21d
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
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 07, 2004
C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
22d
Cleared
Jun 23, 2004
DIGITAL FUNDUS CAMERA, MODEL CF-60DSI
HKI
Camera, Ophthalmic, Ac-powered
14d
Cleared
Jun 22, 2004
ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA
MPA
Endoilluminator
55d
Cleared
Jun 10, 2004
RE-USEABLE MICROSTAAR INJECTOR, MSI-S
KYB
Lens, Guide, Intraocular
310d
Cleared
May 24, 2004
RTA MODEL D RETINAL THICKNESS ANALYZER
HLI
Ophthalmoscope, Ac-powered
11d
Cleared
Mar 26, 2004
PRIZM KERATOME BLADE, MODEL MK8512M2
HNO
Keratome, Ac-powered
172d
Cleared
Mar 22, 2004
ZYOPTIX XP MICROKERATOME
HNO
Keratome, Ac-powered
53d
Cleared
Mar 19, 2004
OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
HQD
Lens, Contact (other Material) - Daily
127d
Cleared
Mar 12, 2004
CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS
LPL
Lenses, Soft Contact, Daily Wear
85d
Cleared
Feb 10, 2004
MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK
HQF
Laser, Ophthalmic
53d
Cleared
Feb 02, 2004
AQUIFY MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
77d
Cleared
Jan 30, 2004
PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
HNO
Keratome, Ac-powered
121d
Cleared
Dec 17, 2003
VENTURI PHACO PACK
HQC
Unit, Phacofragmentation
26d
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