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
Jan 23, 2007
CF-1
HKI
Camera, Ophthalmic, Ac-powered
40d
Cleared
Dec 19, 2006
BAUSCH & LOMB NGX MICROSURGICAL SYSTEM
HQC
Unit, Phacofragmentation
46d
Cleared
Nov 22, 2006
PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS
MVN
Lens, Contact, (disposable)
135d
Cleared
Nov 14, 2006
CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS
LPL
Lenses, Soft Contact, Daily Wear
102d
Cleared
Nov 06, 2006
CRYOMATIC
HRN
Unit, Cryophthalmic, Ac-powered
81d
Cleared
Sep 06, 2006
ZYOPTIX XP EPI SEPARATOR SYSTEM
HNO
Keratome, Ac-powered
13d
Cleared
May 23, 2006
VANTAGE INDIRECT OPHTHALMOSCOPE
HLI
Ophthalmoscope, Ac-powered
57d
Cleared
Mar 03, 2006
TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER
HKY
Tonometer, Manual
84d
Cleared
Dec 06, 2005
BIOFINITY (COMFILCON A) SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
81d
Cleared
Nov 02, 2005
VISUCAM PRO NM
HKI
Camera, Ophthalmic, Ac-powered
75d
Cleared
Sep 30, 2005
FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES
HQF
Laser, Ophthalmic
74d
Cleared
Sep 09, 2005
SOLO-CARE AQUA ANTIMICROBIAL LENS CASE
LRX
Case, Contact Lens
430d
Cleared
Aug 24, 2005
OPD-STATION SOFTWARE
NCF
Aberrometer, Ophthalmic
195d
Cleared
Aug 10, 2005
AQUIFY MULTIPURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
188d
Cleared
May 27, 2005
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES
MVN
Lens, Contact, (disposable)
135d
Cleared
May 18, 2005
PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
33d
Cleared
May 13, 2005
PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC
LPL
Lenses, Soft Contact, Daily Wear
53d
Cleared
Apr 26, 2005
MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
91d
Cleared
Mar 28, 2005
FRESHLOOK ONE-DAY COLOR CONTACT LENS
MVN
Lens, Contact, (disposable)
56d
Cleared
Feb 14, 2005
VISCUCAM C DIGITAL CAMERA
HKI
Camera, Ophthalmic, Ac-powered
84d
Cleared
Nov 16, 2004
FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
35d
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 26, 2004
COOPER PROSTHETIC
LPL
Lenses, Soft Contact, Daily Wear
48d
Cleared
Aug 16, 2004
PHACO CHOP NEEDLES
HQC
Unit, Phacofragmentation
21d
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