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
Oct 15, 2008
CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS
MVN
Lens, Contact, (disposable)
224d
Cleared
Oct 09, 2008
OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES
HQD
Lens, Contact (other Material) - Daily
167d
Cleared
Oct 08, 2008
VITRECTOMY CUTTER AND ACCESSORIES
MLZ
Vitrectomy, Instrument Cutter
113d
Cleared
Oct 02, 2008
ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30
MSS
Folders And Injectors, Intraocular Lens (iol)
122d
Cleared
Sep 30, 2008
IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR
NFJ
System, Image Management, Ophthalmic
43d
Cleared
Sep 29, 2008
PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR
LPL
Lenses, Soft Contact, Daily Wear
90d
Cleared
Sep 23, 2008
MENICON Z RIGID GAS PERMEABLE CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
124d
Cleared
Sep 22, 2008
VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551
HQC
Unit, Phacofragmentation
185d
Cleared
Sep 12, 2008
SOLX 790 TITANIUM SAPPHIRE LASER
HQF
Laser, Ophthalmic
81d
Cleared
Sep 11, 2008
PARKONE
MXK
Device, Analysis, Anterior Segment
273d
Cleared
Sep 11, 2008
SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS
GEX
Powered Laser Surgical Instrument
86d
Cleared
Sep 11, 2008
CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
23d
Cleared
Sep 09, 2008
GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72
HJO
Biomicroscope, Slit-lamp, Ac-powered
174d
Cleared
Sep 05, 2008
RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06
MSS
Folders And Injectors, Intraocular Lens (iol)
105d
Cleared
Aug 28, 2008
BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK
HQC
Unit, Phacofragmentation
30d
Cleared
Aug 07, 2008
OCULAR RESPONSE ANALYZER
HKX
Tonometer, Ac-powered
48d
Cleared
Aug 01, 2008
CARRIAZO-PENDULAR MICROKERATOME
HNO
Keratome, Ac-powered
14d
Cleared
Jul 31, 2008
APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES
HJO
Biomicroscope, Slit-lamp, Ac-powered
14d
Cleared
Jul 23, 2008
REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT
LPL
Lenses, Soft Contact, Daily Wear
149d
Cleared
Jul 18, 2008
ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER
MPA
Endoilluminator
190d
Cleared
Jul 03, 2008
INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT
LPL
Lenses, Soft Contact, Daily Wear
190d
Cleared
Jul 02, 2008
INTEGRE PRO, MODEL L2RY
HQF
Laser, Ophthalmic
28d
Cleared
Jun 24, 2008
CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES)
HJO
Biomicroscope, Slit-lamp, Ac-powered
263d
Cleared
Jun 20, 2008
DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2
KYB
Lens, Guide, Intraocular
241d
Cleared
Jun 11, 2008
MODIFICATION TO RETINAL FUNCTION IMAGER (RFI)
HKI
Camera, Ophthalmic, Ac-powered
139d
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