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
2886 Ophthalmic devices
Cleared
Oct 20, 2009
ALCON ULTRACHOPPER
HQC
Unit, Phacofragmentation
125d
Cleared
Aug 10, 2009
GDX VCC WITH ECC SOFTWARE
MYC
Ophthalmoscope, Laser, Scanning
391d
Cleared
Aug 07, 2009
KOWA, FM-600, MODEL LSS50
MYC
Ophthalmoscope, Laser, Scanning
116d
Cleared
Aug 07, 2009
KOWAGENESIS-DF
HKI
Camera, Ophthalmic, Ac-powered
113d
Cleared
Jul 09, 2009
REFRESH OPTIVE LENS COMFORT REWETTING DROPS
LPN
Accessories, Soft Lens Products
199d
Cleared
Jul 02, 2009
KOWA VX-10 A
HKI
Camera, Ophthalmic, Ac-powered
22d
Cleared
Jun 16, 2009
SUPRA 577.Y LASER
HQF
Laser, Ophthalmic
14d
Cleared
Jun 09, 2009
EPIPHANY INJECTION SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
138d
Cleared
May 05, 2009
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000
OBO
Tomography, Optical Coherence
179d
Cleared
Apr 14, 2009
CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
165d
Cleared
Mar 25, 2009
SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR
HQF
Laser, Ophthalmic
260d
Cleared
Mar 25, 2009
FORUM
NFJ
System, Image Management, Ophthalmic
33d
Cleared
Mar 23, 2009
DIGITAL RETINAL CAMERA, CR-1 MARK II
HKI
Camera, Ophthalmic, Ac-powered
30d
Cleared
Feb 12, 2009
INFINITI VISION SYSTEM WITH OZIL IP
HQC
Unit, Phacofragmentation
139d
Cleared
Jan 16, 2009
EPIVISION SL SYSTEM
HNO
Keratome, Ac-powered
535d
Cleared
Jan 16, 2009
MODIFICATION TO KOWA NONMYD ALPHA-DIII
HKI
Camera, Ophthalmic, Ac-powered
60d
Cleared
Jan 13, 2009
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS
OBO
Tomography, Optical Coherence
449d
Cleared
Jan 05, 2009
BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM
HQC
Unit, Phacofragmentation
131d
Cleared
Nov 18, 2008
NON-CONTACT TONOMETER, MODEL FT-1000
HKX
Tonometer, Ac-powered
383d
Cleared
Oct 21, 2008
KOWA NONMYD ALPHA-DIII
HKI
Camera, Ophthalmic, Ac-powered
29d
Cleared
Oct 16, 2008
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
14d
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
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 11, 2008
SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS
GEX
Powered Laser Surgical Instrument
86d
Looking for a specific ophthalmic device? Search by device name, K-number or manufacturer.
Search all Ophthalmic 510(k) devices