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 02, 2009
OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000
OBO
Tomography, Optical Coherence
21d
Cleared
Sep 01, 2009
F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY
HQP
Unit, Cautery, Thermal, Battery-powered
286d
Cleared
Aug 14, 2009
LENSX 550 LASER SYSTEM
OOE
Ophthalmic Femtosecond Laser
316d
Cleared
Aug 13, 2009
LIGHTLAS SELECTOR
HQF
Laser, Ophthalmic
143d
Cleared
Aug 10, 2009
GDX VCC WITH ECC SOFTWARE
MYC
Ophthalmoscope, Laser, Scanning
391d
Cleared
Aug 07, 2009
KOWA, FM-600, MODEL LSS50
MYC
Ophthalmoscope, Laser, Scanning
116d
Cleared
Aug 07, 2009
KOWAGENESIS-DF
HKI
Camera, Ophthalmic, Ac-powered
113d
Cleared
Jul 28, 2009
NAVIJECT SUB2-1P, MODEL: LP604430
MSS
Folders And Injectors, Intraocular Lens (iol)
22d
Cleared
Jul 27, 2009
ACCUPEN
HKX
Tonometer, Ac-powered
255d
Cleared
Jul 09, 2009
XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM
MSS
Folders And Injectors, Intraocular Lens (iol)
283d
Cleared
Jul 09, 2009
REFRESH OPTIVE LENS COMFORT REWETTING DROPS
LPN
Accessories, Soft Lens Products
199d
Cleared
Jul 02, 2009
KOWA VX-10 A
HKI
Camera, Ophthalmic, Ac-powered
22d
Cleared
Jun 30, 2009
RETINA CAMERA TRC-NW7SF MARK II
HKI
Camera, Ophthalmic, Ac-powered
160d
Cleared
Jun 16, 2009
STATIC VESSEL ANALYZER
HKI
Camera, Ophthalmic, Ac-powered
316d
Cleared
Jun 16, 2009
EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
260d
Cleared
Jun 16, 2009
EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
260d
Cleared
Jun 16, 2009
EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
260d
Cleared
Jun 16, 2009
SUPRA 577.Y LASER
HQF
Laser, Ophthalmic
14d
Cleared
Jun 09, 2009
EPIPHANY INJECTION SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
138d
Cleared
Jun 04, 2009
FLOW CONTROLLER
LZU
Plug, Punctum
62d
Cleared
May 20, 2009
SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
140d
Cleared
May 08, 2009
KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT
NXM
Prosthesis, Eyelid Spacer/graft, Biologic
116d
Cleared
May 06, 2009
MATCHEDFLICKER
NFJ
System, Image Management, Ophthalmic
92d
Cleared
May 05, 2009
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000
OBO
Tomography, Optical Coherence
179d
Cleared
Apr 14, 2009
CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
165d
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