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
May 10, 2013
TRC-NW8 NON-MYDRIATIC RETINAL CAMERA
HKI
Camera, Ophthalmic, Ac-powered
94d
Cleared
Apr 30, 2013
PEREGRINE 23GA CURVED LASER PROBE
HQB
Photocoagulator And Accessories
221d
Cleared
Apr 23, 2013
AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
118d
Cleared
Apr 15, 2013
Z CARTRIDGE IOL DELIVERY SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
118d
Cleared
Apr 12, 2013
IOLMASTER 500
HJO
Biomicroscope, Slit-lamp, Ac-powered
247d
Cleared
Apr 03, 2013
PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS
LRX
Case, Contact Lens
57d
Cleared
Apr 02, 2013
EXCELSIOR
NFJ
System, Image Management, Ophthalmic
39d
Cleared
Mar 29, 2013
SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
136d
Cleared
Mar 27, 2013
TBD
OOE
Ophthalmic Femtosecond Laser
103d
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
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