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
Apr 30, 2012
OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION
LPN
Accessories, Soft Lens Products
210d
Cleared
Apr 26, 2012
GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
398d
Cleared
Apr 23, 2012
SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE
HQB
Photocoagulator And Accessories
115d
Cleared
Apr 18, 2012
SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
135d
Cleared
Apr 17, 2012
AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
104d
Cleared
Apr 11, 2012
KONAN SPECULAR MICROSCOPE XIV
NQE
Microscope, Specular
72d
Cleared
Apr 03, 2012
AVAIRA (ENFILCON A) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
104d
Cleared
Apr 03, 2012
RTVUE XR OCT
HLI
Ophthalmoscope, Ac-powered
68d
Cleared
Mar 30, 2012
DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC
LPL
Lenses, Soft Contact, Daily Wear
155d
Cleared
Mar 27, 2012
MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)
MSS
Folders And Injectors, Intraocular Lens (iol)
173d
Cleared
Mar 16, 2012
FEMTO LDV
HQF
Laser, Ophthalmic
233d
Cleared
Feb 16, 2012
KOWA VX-20
HKI
Camera, Ophthalmic, Ac-powered
188d
Cleared
Jan 24, 2012
EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION
LPN
Accessories, Soft Lens Products
207d
Cleared
Jan 19, 2012
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES
OBO
Tomography, Optical Coherence
269d
Cleared
Dec 29, 2011
TRIMOTION INJECTOR
OTZ
Graft Insertion Instrument For Endothelial Keratoplasty
447d
Cleared
Dec 21, 2011
SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM
HQC
Unit, Phacofragmentation
211d
Cleared
Dec 21, 2011
PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
132d
Cleared
Dec 21, 2011
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
OOE
Ophthalmic Femtosecond Laser
28d
Cleared
Dec 19, 2011
LIPIFLOW THERMAL PULSATION SYSTEM
ORZ
Eyelid Thermal Pulsation System
94d
Cleared
Dec 08, 2011
CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
HRN
Unit, Cryophthalmic, Ac-powered
139d
Cleared
Dec 05, 2011
EYE CARE CURE CONTACT LENS CASE
LRX
Case, Contact Lens
67d
Cleared
Dec 02, 2011
AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL
LPL
Lenses, Soft Contact, Daily Wear
30d
Cleared
Dec 02, 2011
BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC
LPL
Lenses, Soft Contact, Daily Wear
28d
Cleared
Nov 30, 2011
NON-CONTACT TEAR FILM THERMOGRAGH
HKI
Camera, Ophthalmic, Ac-powered
160d
Cleared
Nov 22, 2011
FEMTEC LASER SYSTEM FOR CAPSULOTOMY
OOE
Ophthalmic Femtosecond Laser
281d
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