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
Nov 29, 2007
CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
MVN
Lens, Contact, (disposable)
30d
Cleared
Nov 07, 2007
ROYALE AE 9036 LSP INJECTOR
MSS
Folders And Injectors, Intraocular Lens (iol)
13d
Cleared
Nov 05, 2007
NEXT GENERATION LASER
HQF
Laser, Ophthalmic
426d
Cleared
Nov 05, 2007
PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36
HLJ
Ophthalmoscope, Battery-powered
280d
Cleared
Nov 01, 2007
IOL INJECTOR SET
KYB
Lens, Guide, Intraocular
234d
Cleared
Sep 28, 2007
CA, MODEL: CAM
OBO
Tomography, Optical Coherence
147d
Cleared
Sep 20, 2007
LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR
HQF
Laser, Ophthalmic
323d
Cleared
Aug 31, 2007
IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP
NFJ
System, Image Management, Ophthalmic
114d
Cleared
Aug 15, 2007
BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
100d
Cleared
Aug 08, 2007
MEDPOR ATTRACTOR IMPLANT
HPZ
Implant, Eye Sphere
89d
Cleared
Aug 06, 2007
BENZ-G 4X HIOXIFILCON D
LPL
Lenses, Soft Contact, Daily Wear
315d
Cleared
Aug 02, 2007
TRUEFIELD ANALYZER
HPT
Perimeter, Automatic, Ac-powered
273d
Cleared
Aug 02, 2007
BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES
HQD
Lens, Contact (other Material) - Daily
112d
Cleared
Jul 24, 2007
EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION
LPN
Accessories, Soft Lens Products
126d
Cleared
Jul 20, 2007
ALLEGRO OCULYZER
MXK
Device, Analysis, Anterior Segment
81d
Cleared
Jun 22, 2007
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM
OBO
Tomography, Optical Coherence
226d
Cleared
Jun 13, 2007
SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES
LPN
Accessories, Soft Lens Products
43d
Cleared
Jun 07, 2007
CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
281d
Cleared
May 23, 2007
ICARE TONOMETER TA01I
HKY
Tonometer, Manual
145d
Cleared
May 07, 2007
LENSTEC LC INJECTION SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
136d
Cleared
May 01, 2007
OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.
HQD
Lens, Contact (other Material) - Daily
55d
Cleared
May 01, 2007
FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES
HQD
Lens, Contact (other Material) - Daily
55d
Cleared
May 01, 2007
CONTACT LENS CASE
LRX
Case, Contact Lens
14d
Cleared
Apr 25, 2007
ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION
LPN
Accessories, Soft Lens Products
258d
Cleared
Apr 24, 2007
ORION
HKI
Camera, Ophthalmic, Ac-powered
90d
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