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
5110
Total
5092
Cleared
168d
Avg (2y)
1976
Since
2900 Ophthalmic devices
Cleared
Sep 26, 1988
SLT CONTACT LASER SYSTEM ENDOPHOTOCOAGULATION
HQB
Photocoagulator And Accessories
104d
Cleared
Sep 15, 1988
SITE MACROBORE PHACO NEEDLE
HQC
Unit, Phacofragmentation
55d
Cleared
Sep 15, 1988
MODIFICATION TO THE SITE PERISTALTIC MODULE SYSTEM
HQC
Unit, Phacofragmentation
49d
Cleared
Sep 15, 1988
NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)
HQF
Laser, Ophthalmic
48d
Cleared
Sep 12, 1988
MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE
HMG
Stand, Instrument, Ophthalmic, Non-powered
21d
Cleared
Aug 24, 1988
MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE
FCT
Headlight, Fiberoptic Focusing
8d
Cleared
Aug 18, 1988
CANON AUTOREFRACTOMETER R-22
HKO
Refractometer, Ophthalmic
21d
Cleared
Aug 04, 1988
STORZ INFUSION CANNULA
HMX
Cannula, Ophthalmic
24d
Cleared
Aug 02, 1988
RESUBMITTED DIODE LASER COAGULATOR
HQF
Laser, Ophthalmic
68d
Cleared
Jul 29, 1988
BOLDREY PERIPHERAL RETINAL LENS
LQJ
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
37d
Cleared
Jul 01, 1988
ALCON SITE(R)-COMPATIBLE CASSETTE
KYG
Device, Irrigation, Ocular Surgery
73d
Cleared
Jul 01, 1988
SITE ULTRASONIC I/A PHACO NEEDLE
HQC
Unit, Phacofragmentation
43d
Cleared
Jul 01, 1988
NIDEK ARK-2000
HKO
Refractometer, Ophthalmic
38d
Cleared
Jul 01, 1988
CANON AUTOREFRACTOMETER R-20
HKO
Refractometer, Ophthalmic
30d
Cleared
Jun 06, 1988
SLT CONTACT LASER SYSTEM OCULOPLASTICS
HQF
Laser, Ophthalmic
82d
Cleared
Jun 06, 1988
REUSABLE FIBEROPTIC LIGHTPIPE
HQB
Photocoagulator And Accessories
28d
Cleared
May 25, 1988
NIDEK CV-4000
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
82d
Cleared
May 25, 1988
PRISMA TECH 19 GAUGE DISPOSABLE EXTRUSION NEEDLES
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
16d
Cleared
May 13, 1988
PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS
LXP
Plug, Scleral
67d
Cleared
May 13, 1988
ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG
LXP
Plug, Scleral
67d
Cleared
May 13, 1988
MENTOR WET-FIELD*II COAGULATOR
HQQ
Apparatus, Cautery, Radiofrequency, Battery-powered
65d
Cleared
May 13, 1988
MVR/STILETTO BLADE 20GA. - P/N 1900
HNN
Knife, Ophthalmic
25d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE GILLS ANGLED I/A CANNULA
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOSABLE KRATZ CAPSULE POLISHER
HMX
Cannula, Ophthalmic
133d
Cleared
Apr 13, 1988
PRISMA DISPOS. TROUTMAN ALPHA-CHYMOTRYPSIN CANNULA
HMX
Cannula, Ophthalmic
133d
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