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
2887 Ophthalmic devices
Cleared
May 24, 2006
CONTACT LENS OPHTHALMODYNAMOMETER
NYK
Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (pmma)
239d
Cleared
May 23, 2006
VANTAGE INDIRECT OPHTHALMOSCOPE
HLI
Ophthalmoscope, Ac-powered
57d
Cleared
May 22, 2006
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788
MSS
Folders And Injectors, Intraocular Lens (iol)
41d
Cleared
May 18, 2006
SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
52d
Cleared
May 16, 2006
OPTYSE OPHTHALMOSCOPE
HLJ
Ophthalmoscope, Battery-powered
8d
Cleared
May 15, 2006
AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
265d
Cleared
May 15, 2006
SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES
MVN
Lens, Contact, (disposable)
221d
Cleared
May 12, 2006
DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS
MVN
Lens, Contact, (disposable)
178d
Cleared
May 11, 2006
RS-1000 ZOOM SLITLAMP WITH OPTION
HJO
Biomicroscope, Slit-lamp, Ac-powered
42d
Cleared
May 09, 2006
ALPHASPHERE ORBITAL IMPLANT
HPZ
Implant, Eye Sphere
165d
Cleared
May 02, 2006
EAGLEVISION GELLANSERTS, MODEL REF 0040
LZU
Plug, Punctum
152d
Cleared
Apr 14, 2006
LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
45d
Cleared
Apr 07, 2006
THE AMO OPHTHALMIC SURGICAL SYSTEM
HQC
Unit, Phacofragmentation
53d
Cleared
Apr 06, 2006
TONOMETER DIATON
HKX
Tonometer, Ac-powered
15d
Cleared
Mar 23, 2006
HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM
HNO
Keratome, Ac-powered
161d
Cleared
Mar 17, 2006
EYEPORT VISION TRAINING SYSTEM
NXR
Fixation, Vision Training, Binocular
267d
Cleared
Mar 17, 2006
PANORAMIC, MODEL 200MA
MYC
Ophthalmoscope, Laser, Scanning
28d
Cleared
Mar 15, 2006
SURGISIS OCULAR GRAFT
NXM
Prosthesis, Eyelid Spacer/graft, Biologic
77d
Cleared
Mar 15, 2006
SYNERGEYES PS HYBRID CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
61d
Cleared
Mar 10, 2006
MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC)
LPL
Lenses, Soft Contact, Daily Wear
280d
Cleared
Mar 03, 2006
TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER
HKY
Tonometer, Manual
84d
Cleared
Mar 03, 2006
OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450
HMR
Marker, Ocular
79d
Cleared
Feb 10, 2006
FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES
HQD
Lens, Contact (other Material) - Daily
109d
Cleared
Jan 30, 2006
BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES
HQD
Lens, Contact (other Material) - Daily
84d
Cleared
Jan 30, 2006
DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797
MSS
Folders And Injectors, Intraocular Lens (iol)
77d
Looking for a specific ophthalmic device? Search by device name, K-number or manufacturer.
Search all Ophthalmic 510(k) devices