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
Jan 24, 2006
OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5
HKI
Camera, Ophthalmic, Ac-powered
88d
Cleared
Jan 19, 2006
C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02
MSS
Folders And Injectors, Intraocular Lens (iol)
115d
Cleared
Jan 13, 2006
HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)
MXK
Device, Analysis, Anterior Segment
86d
Cleared
Jan 09, 2006
PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS
HLJ
Ophthalmoscope, Battery-powered
32d
Cleared
Dec 15, 2005
MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
84d
Cleared
Dec 09, 2005
FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300
NCR
Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-powered
239d
Cleared
Dec 06, 2005
BIOFINITY (COMFILCON A) SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
81d
Cleared
Nov 30, 2005
SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS
HQD
Lens, Contact (other Material) - Daily
64d
Cleared
Nov 10, 2005
ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL
LPL
Lenses, Soft Contact, Daily Wear
43d
Cleared
Nov 10, 2005
KOWA NONMYD 7, KOWA NONMYD A-D
HKI
Camera, Ophthalmic, Ac-powered
14d
Cleared
Nov 03, 2005
KOWA GENESIS-D HAND-HELD RETINAL CAMERA
HKI
Camera, Ophthalmic, Ac-powered
272d
Cleared
Nov 02, 2005
VISUCAM PRO NM
HKI
Camera, Ophthalmic, Ac-powered
75d
Cleared
Nov 02, 2005
TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR
HQD
Lens, Contact (other Material) - Daily
50d
Cleared
Nov 02, 2005
SAUFLON FLAT COLOURED LENS CASE
LRX
Case, Contact Lens
29d
Cleared
Oct 06, 2005
KOWA VX-10
HKI
Camera, Ophthalmic, Ac-powered
321d
Cleared
Sep 30, 2005
VISANTE OCT
HLI
Ophthalmoscope, Ac-powered
91d
Cleared
Sep 30, 2005
FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES
HQF
Laser, Ophthalmic
74d
Cleared
Sep 28, 2005
CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA
MXK
Device, Analysis, Anterior Segment
72d
Cleared
Sep 23, 2005
REPROCESSED PHACOEMUISIFICATION TIPS
NKX
Needle, Phacoemulsification, Reprocessed
206d
Cleared
Sep 21, 2005
20G SMA LASER FIBER, MODEL LF100
HQF
Laser, Ophthalmic
175d
Cleared
Sep 14, 2005
ALCON MULTI-PURPOSE DISINFECTING SOLUTION
LPN
Accessories, Soft Lens Products
177d
Cleared
Sep 09, 2005
SOLO-CARE AQUA ANTIMICROBIAL LENS CASE
LRX
Case, Contact Lens
430d
Cleared
Sep 02, 2005
SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
133d
Cleared
Sep 01, 2005
JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS
MRC
Products, Contact Lens Care, Rigid Gas Permeable
31d
Cleared
Aug 24, 2005
OPD-STATION SOFTWARE
NCF
Aberrometer, Ophthalmic
195d
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