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
Mar 05, 2013
CALLISTO EYE
NFJ
System, Image Management, Ophthalmic
116d
Cleared
Feb 21, 2013
DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL
LPL
Lenses, Soft Contact, Daily Wear
57d
Cleared
Dec 21, 2012
CENTURION VISION SYSTEM
HQC
Unit, Phacofragmentation
210d
Cleared
Dec 20, 2012
PANOPTIC
HKI
Camera, Ophthalmic, Ac-powered
224d
Cleared
Dec 20, 2012
BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI
LPL
Lenses, Soft Contact, Daily Wear
119d
Cleared
Nov 02, 2012
FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH
NFJ
System, Image Management, Ophthalmic
39d
Cleared
Oct 19, 2012
LACRICATH LACRIMAL DUCT CATHETER
OKS
Lacrimal Stents And Intubation Sets
294d
Cleared
Sep 28, 2012
BAUSCH & LOMB IOL INJECTOR
MSS
Folders And Injectors, Intraocular Lens (iol)
274d
Cleared
Jul 31, 2012
STENTUBE LACRIMAL INTUBATION SET
OKS
Lacrimal Stents And Intubation Sets
284d
Cleared
Apr 30, 2012
OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION
LPN
Accessories, Soft Lens Products
210d
Cleared
Apr 03, 2012
AVAIRA (ENFILCON A) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
104d
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
Jan 24, 2012
EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION
LPN
Accessories, Soft Lens Products
207d
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 08, 2011
CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
HRN
Unit, Cryophthalmic, Ac-powered
139d
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
Oct 25, 2011
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
MVN
Lens, Contact, (disposable)
88d
Cleared
Sep 15, 2011
PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC
LPL
Lenses, Soft Contact, Daily Wear
66d
Cleared
Sep 14, 2011
DIGITAL RETINAL CAMERA
HKI
Camera, Ophthalmic, Ac-powered
97d
Cleared
Jun 29, 2011
PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
167d
Cleared
May 11, 2011
INTEGRA LED SURGICAL HEADLIGHT SYSTEM
FSR
Light, Headband, Surgical
76d
Cleared
Feb 01, 2011
VISULAS TRION LASER SYSTEM WITH THE VITE OPTION
HQF
Laser, Ophthalmic
109d
Cleared
Dec 10, 2010
PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000
HKX
Tonometer, Ac-powered
415d
Cleared
Nov 19, 2010
OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
HLJ
Ophthalmoscope, Battery-powered
374d
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