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
2885 Ophthalmic devices
Cleared
Mar 22, 2013
HEINE MINI 3000 LED OPHTHALMOSCOPE
HLJ
Ophthalmoscope, Battery-powered
121d
Cleared
Mar 19, 2013
ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S
LPL
Lenses, Soft Contact, Daily Wear
237d
Cleared
Mar 19, 2013
DIGITAL RETINAL CAMERA
HKI
Camera, Ophthalmic, Ac-powered
158d
Cleared
Mar 14, 2013
NIDEK RS-3000
OBO
Tomography, Optical Coherence
286d
Cleared
Mar 05, 2013
CALLISTO EYE
NFJ
System, Image Management, Ophthalmic
116d
Cleared
Feb 26, 2013
HEINE OMEGA 500
HLI
Ophthalmoscope, Ac-powered
124d
Cleared
Feb 22, 2013
OPTOS OCT/SLO MICROPERIMETER
OBO
Tomography, Optical Coherence
323d
Cleared
Feb 22, 2013
MYVISIONTRACK(TM)
HOQ
Grid, Amsler
254d
Cleared
Feb 21, 2013
DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL
LPL
Lenses, Soft Contact, Daily Wear
57d
Cleared
Feb 15, 2013
FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILC
LPL
Lenses, Soft Contact, Daily Wear
198d
Cleared
Feb 08, 2013
VICTUS FEMTOSECOND LASER PLATFORM
OOE
Ophthalmic Femtosecond Laser
186d
Cleared
Feb 06, 2013
TRC-NW300 NON-MYDRIATIC RETINAL CAMERA
HKI
Camera, Ophthalmic, Ac-powered
89d
Cleared
Jan 31, 2013
CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE
MYC
Ophthalmoscope, Laser, Scanning
489d
Cleared
Jan 31, 2013
DURETTE OCULAR IMPLANT
HPZ
Implant, Eye Sphere
55d
Cleared
Jan 18, 2013
IVUE WITH NORMATIVE DATABASE
HLI
Ophthalmoscope, Ac-powered
219d
Cleared
Jan 11, 2013
ICAM FUNDUS CAMERA
HKI
Camera, Ophthalmic, Ac-powered
141d
Cleared
Jan 02, 2013
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS
MRC
Products, Contact Lens Care, Rigid Gas Permeable
156d
Cleared
Dec 31, 2012
LIPIVIEW OCULAR SURFACE INTERFEROMETER
HKI
Camera, Ophthalmic, Ac-powered
139d
Cleared
Dec 21, 2012
CENTURION VISION SYSTEM
HQC
Unit, Phacofragmentation
210d
Cleared
Dec 20, 2012
PANOPTIC
HKI
Camera, Ophthalmic, Ac-powered
224d
Cleared
Dec 20, 2012
BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI
LPL
Lenses, Soft Contact, Daily Wear
119d
Cleared
Dec 17, 2012
LACRIFAST
OKS
Lacrimal Stents And Intubation Sets
269d
Cleared
Dec 12, 2012
ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
140d
Cleared
Dec 12, 2012
LENSX LASER SYSTEM
OOE
Ophthalmic Femtosecond Laser
70d
Cleared
Dec 03, 2012
LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS
HQC
Unit, Phacofragmentation
77d
Looking for a specific ophthalmic device? Search by device name, K-number or manufacturer.
Search all Ophthalmic 510(k) devices