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
5106
Total
5088
Cleared
170d
Avg (2y)
1976
Since
1303 Ophthalmic devices
Cleared
Feb 03, 2017
LenSx Laser System
OOE
Ophthalmic Femtosecond Laser
46d
Cleared
Nov 30, 2016
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
LPL
Lenses, Soft Contact, Daily Wear
195d
Cleared
Nov 16, 2016
LenSX Laser System
OOE
Ophthalmic Femtosecond Laser
191d
Cleared
Oct 19, 2016
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
LPN
Accessories, Soft Lens Products
30d
Cleared
Oct 13, 2016
AIR OPTIX COLORS
LPL
Lenses, Soft Contact, Daily Wear
27d
Cleared
Jul 13, 2016
Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
112d
Cleared
May 02, 2016
AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric
LPL
Lenses, Soft Contact, Daily Wear
60d
Cleared
Jan 20, 2016
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal
LPL
Lenses, Soft Contact, Daily Wear
30d
Cleared
Jan 20, 2016
Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
LPL
Lenses, Soft Contact, Daily Wear
30d
Cleared
May 22, 2015
Bausch + Lomb Injector System
MSS
Folders And Injectors, Intraocular Lens (iol)
28d
Cleared
May 21, 2015
Retina Workplace
NFJ
System, Image Management, Ophthalmic
87d
Cleared
Jan 26, 2015
CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE
LPN
Accessories, Soft Lens Products
161d
Cleared
Nov 18, 2014
RESCAN 700, CALLISTO EYE
OBO
Tomography, Optical Coherence
133d
Cleared
Oct 03, 2014
FORUM GLAUCOMA WORKPLACE
NFJ
System, Image Management, Ophthalmic
137d
Cleared
Sep 09, 2014
ZEISS CATARACT SUITE MARKERLESS
HJO
Biomicroscope, Slit-lamp, Ac-powered
138d
Cleared
Mar 19, 2014
CIRRUS PHOTO
OBO
Tomography, Optical Coherence
152d
Cleared
Feb 12, 2014
SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION
HJO
Biomicroscope, Slit-lamp, Ac-powered
92d
Cleared
Jan 29, 2014
AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL
LPL
Lenses, Soft Contact, Daily Wear
104d
Cleared
Dec 23, 2013
AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
27d
Cleared
Nov 01, 2013
SCANNING LASERLINK
HQF
Laser, Ophthalmic
277d
Cleared
Sep 11, 2013
BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,
LPL
Lenses, Soft Contact, Daily Wear
135d
Cleared
Aug 30, 2013
SUS (STENFILCON A) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
108d
Cleared
Jul 23, 2013
FORUM GLAUCOMA WORKPLACE
NFJ
System, Image Management, Ophthalmic
134d
Cleared
May 30, 2013
PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
230d
Cleared
Apr 12, 2013
IOLMASTER 500
HJO
Biomicroscope, Slit-lamp, Ac-powered
247d
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