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
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
HOYA IS INJECTOR SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
313d
Cleared
Mar 23, 2009
DIGITAL RETINAL CAMERA, CR-1 MARK II
HKI
Camera, Ophthalmic, Ac-powered
30d
Cleared
Mar 13, 2009
3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM
OBO
Tomography, Optical Coherence
123d
Cleared
Mar 12, 2009
ORBITAL RECONSTRUCTIVE IMPLANT II
HPZ
Implant, Eye Sphere
120d
Cleared
Feb 27, 2009
EYE SPHERES
HPZ
Implant, Eye Sphere
151d
Cleared
Feb 27, 2009
IMAG, IPOD, EZ-FIND AND ISLIDE
LRX
Case, Contact Lens
14d
Cleared
Feb 12, 2009
INFINITI VISION SYSTEM WITH OZIL IP
HQC
Unit, Phacofragmentation
139d
Cleared
Jan 30, 2009
RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP
HKI
Camera, Ophthalmic, Ac-powered
43d
Cleared
Jan 27, 2009
HDS HI 1.54
HQD
Lens, Contact (other Material) - Daily
126d
Cleared
Jan 22, 2009
IMAGE STORAGE SYSTEM, MODEL KSS-400
NFJ
System, Image Management, Ophthalmic
211d
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
ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS
HQC
Unit, Phacofragmentation
187d
Cleared
Jan 05, 2009
BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM
HQC
Unit, Phacofragmentation
131d
Cleared
Dec 17, 2008
POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
272d
Cleared
Dec 15, 2008
CENEFOM PVA SURGICAL SPEAR
HOZ
Sponge, Ophthalmic
111d
Cleared
Nov 18, 2008
NON-CONTACT TONOMETER, MODEL FT-1000
HKX
Tonometer, Ac-powered
383d
Cleared
Nov 14, 2008
SPECTRAL OCT/SLO
OBO
Tomography, Optical Coherence
268d
Cleared
Nov 05, 2008
RETCAM 3 OPHTHALMIC IMAGING SYSTEM
HKI
Camera, Ophthalmic, Ac-powered
127d
Cleared
Oct 23, 2008
DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786
KYB
Lens, Guide, Intraocular
160d
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
Looking for a specific ophthalmic device? Search by device name, K-number or manufacturer.
Search all Ophthalmic 510(k) devices