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
Sep 10, 2010
STERILE SALINE SOLUTION
LPN
Accessories, Soft Lens Products
316d
Cleared
Aug 17, 2010
STELLARIS PC VISION ENHANCEMENT SYSTEM
HQC
Unit, Phacofragmentation
97d
Cleared
Aug 09, 2010
BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS
LPL
Lenses, Soft Contact, Daily Wear
110d
Cleared
Aug 09, 2010
VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430
MSS
Folders And Injectors, Intraocular Lens (iol)
109d
Cleared
Jul 16, 2010
MEDIWORKS SLIT LAMP
HJO
Biomicroscope, Slit-lamp, Ac-powered
149d
Cleared
Jul 15, 2010
OPTOS LIMITED PANORAMIC 200CAF
MYC
Ophthalmoscope, Laser, Scanning
132d
Cleared
Jul 08, 2010
VISUMAX LASER KERATOME
HQF
Laser, Ophthalmic
161d
Cleared
Jun 25, 2010
ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
416d
Cleared
Jun 17, 2010
R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100
HLI
Ophthalmoscope, Ac-powered
83d
Cleared
May 27, 2010
MAIA, MODEL 1
HPT
Perimeter, Automatic, Ac-powered
310d
Cleared
May 21, 2010
VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER
LPL
Lenses, Soft Contact, Daily Wear
98d
Cleared
May 13, 2010
LENSAR LASER SYSTEM
OOE
Ophthalmic Femtosecond Laser
430d
Cleared
May 10, 2010
CENTRAL VISION ANALYZER MODEL 1000
HOX
Chart, Visual Acuity
117d
Cleared
May 04, 2010
PASCAL STREAMLINE PHOTOCOAGULATOR
HQF
Laser, Ophthalmic
119d
Cleared
Apr 27, 2010
POLARIS CONTACT LENS CASE
LRX
Case, Contact Lens
180d
Cleared
Apr 23, 2010
LENSX 550 LASER SYSTEM. MODEL 550
OOE
Ophthalmic Femtosecond Laser
113d
Cleared
Apr 22, 2010
IVUE, MODEL 100
OBO
Tomography, Optical Coherence
345d
Cleared
Apr 02, 2010
ENHANCED ULTRA VIT PROBE
MLZ
Vitrectomy, Instrument Cutter
162d
Cleared
Mar 19, 2010
SLIT LAMP BO 900, BQ 900, BP900
HJO
Biomicroscope, Slit-lamp, Ac-powered
53d
Cleared
Mar 18, 2010
DIGITAL RETINAL CAMERA CX-1
HKI
Camera, Ophthalmic, Ac-powered
210d
Cleared
Mar 12, 2010
GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES
HPT
Perimeter, Automatic, Ac-powered
150d
Cleared
Mar 11, 2010
SAVIEW 58 UV
LPL
Lenses, Soft Contact, Daily Wear
176d
Cleared
Mar 09, 2010
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
MRC
Products, Contact Lens Care, Rigid Gas Permeable
526d
Cleared
Mar 09, 2010
PSL CLASSIC SLIT LAMP
HJO
Biomicroscope, Slit-lamp, Ac-powered
15d
Cleared
Mar 04, 2010
AQUALASE CAPSULE WASH TIP
HQC
Unit, Phacofragmentation
142d
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