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
Dec 28, 1988
ALLERGAN LENS CASE
LRX
Case, Contact Lens
78d
Cleared
Dec 14, 1988
SLT CONTACT LASER SYSTEM CYCLOPHOTOCOAGULATION
HQB
Photocoagulator And Accessories
169d
Cleared
Dec 12, 1988
WOODEN SPECTACLE FRAMES
HQZ
Frame, Spectacle
61d
Cleared
Dec 06, 1988
GV3000 PHACOEMULSIFIER/FRAGMENTER
HQC
Unit, Phacofragmentation
137d
Cleared
Nov 30, 1988
MQL 20 ND:YAG OPHTHALMIC LASER
LQJ
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
21d
Cleared
Nov 29, 1988
LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD
HQJ
Implant, Absorbable, (scleral Buckling Methods)
40d
Cleared
Nov 29, 1988
LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL
MOE
Collagen Corneal Shield
40d
Cleared
Nov 29, 1988
LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL
MOE
Collagen Corneal Shield
40d
Cleared
Nov 25, 1988
OCCU-TECH VISION TEST
HOX
Chart, Visual Acuity
198d
Cleared
Nov 23, 1988
NIDEK LM-870 AUTOMATIC LENSMETER
HLM
Instrument, Measuring, Lens, Ac-powered
49d
Cleared
Nov 16, 1988
ORTHOTONE
HLL
Monitor, Eye Movement
534d
Cleared
Nov 16, 1988
DEXSOL
LYX
Media, Corneal Storage
64d
Cleared
Nov 16, 1988
GRIESHABER MICRO LITE LIGHT PIPE 19 & 20 GAUGE
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
51d
Cleared
Nov 15, 1988
.2MM, .4MM, .5MM IRRIGATION AND ASPIRATION HAND.
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
61d
Cleared
Nov 15, 1988
SEIKO P-6 PROGRESSIVE SPECTACLE LENSES
HQG
Lens, Spectacle, Non-custom (prescription)
29d
Cleared
Nov 08, 1988
VKG 1000, VIDEO KERATOMETER
HLP
Target, Fusion And Stereoscopic
84d
Cleared
Nov 07, 1988
OPTIMED ADVANTAGE
HPT
Perimeter, Automatic, Ac-powered
87d
Cleared
Oct 31, 1988
PL 20/20 INFANT VISION TESTER
HOX
Chart, Visual Acuity
83d
Cleared
Oct 25, 1988
KRATZ NOVA SERT(TM)
KYB
Lens, Guide, Intraocular
70d
Cleared
Oct 25, 1988
MODIFIED REUSABLE SITE FIBER OPTIC CABLE
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
63d
Cleared
Oct 25, 1988
DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI.
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
35d
Cleared
Oct 18, 1988
INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM
LQJ
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
48d
Cleared
Oct 13, 1988
IRIS ND:YAG OPTHALMIC LASER
LQJ
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
71d
Cleared
Oct 07, 1988
LENZ CLENZER
LYL
Accessories, Solution, Ultrasonic Cleaners For Lenses
165d
Cleared
Sep 30, 1988
SLT CL60 CONTACT LASER SYSTEM, CUTTING & COAGULA.
HQF
Laser, Ophthalmic
80d
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