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
2887 Ophthalmic devices
Cleared
Apr 24, 2007
SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR
HQF
Laser, Ophthalmic
34d
Cleared
Apr 19, 2007
ORBITAL RECONSTRUCTIVE IMPLANT
HPZ
Implant, Eye Sphere
93d
Cleared
Apr 13, 2007
STARION UNIVERSAL POWER SUPPLY
HQO
Unit, Cautery, Thermal, Ac-powered
15d
Cleared
Mar 27, 2007
MONARCH III IOL DELIVERY SYSTEM
KYB
Lens, Guide, Intraocular
161d
Cleared
Mar 27, 2007
MODIFICATION TO: OCU-FILM TIP COVER
HKY
Tonometer, Manual
29d
Cleared
Mar 19, 2007
REPROCESSED PHACOEMULSIFICATION TIPS
NKX
Needle, Phacoemulsification, Reprocessed
371d
Cleared
Mar 13, 2007
ELLEX SLIT LAMP, MODEL 30XL
HJO
Biomicroscope, Slit-lamp, Ac-powered
127d
Cleared
Mar 12, 2007
FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
39d
Cleared
Mar 09, 2007
KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES
HQP
Unit, Cautery, Thermal, Battery-powered
183d
Cleared
Mar 07, 2007
AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28
KYB
Lens, Guide, Intraocular
84d
Cleared
Feb 08, 2007
EUSOL-C
LYX
Media, Corneal Storage
65d
Cleared
Jan 26, 2007
CIRRUS HD-OCT, MODEL 4000
HLI
Ophthalmoscope, Ac-powered
79d
Cleared
Jan 23, 2007
CF-1
HKI
Camera, Ophthalmic, Ac-powered
40d
Cleared
Dec 20, 2006
XCEL 255 SLIT LAMP
HJO
Biomicroscope, Slit-lamp, Ac-powered
1d
Cleared
Dec 19, 2006
BAUSCH & LOMB NGX MICROSURGICAL SYSTEM
HQC
Unit, Phacofragmentation
46d
Cleared
Dec 18, 2006
KOWA SL-15
HJO
Biomicroscope, Slit-lamp, Ac-powered
11d
Cleared
Dec 13, 2006
RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04
MSS
Folders And Injectors, Intraocular Lens (iol)
99d
Cleared
Dec 13, 2006
BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM
HLI
Ophthalmoscope, Ac-powered
37d
Cleared
Dec 07, 2006
LUXVISION SLIT LAMP
HJO
Biomicroscope, Slit-lamp, Ac-powered
24d
Cleared
Nov 22, 2006
PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS
MVN
Lens, Contact, (disposable)
135d
Cleared
Nov 17, 2006
RETINAL FUNCTIONAL IMAGER (RFI)
HKI
Camera, Ophthalmic, Ac-powered
92d
Cleared
Nov 14, 2006
IRIDEX WIRELESS FOOTSWITCH
HQF
Laser, Ophthalmic
116d
Cleared
Nov 14, 2006
CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS
LPL
Lenses, Soft Contact, Daily Wear
102d
Cleared
Nov 08, 2006
LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
NCF
Aberrometer, Ophthalmic
41d
Cleared
Nov 07, 2006
66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A
HLJ
Ophthalmoscope, Battery-powered
412d
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