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
Dec 15, 1986
YANNUZZI FUNDUS LASER LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
45d
Cleared
Dec 15, 1986
HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN
HOO
Perimeter, Ac-powered
33d
Cleared
Dec 12, 1986
MAINSTER RETINA LASER LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
65d
Cleared
Nov 28, 1986
LANDERS INDIRECT VITRECTOMY LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
18d
Cleared
Nov 13, 1986
FAULKNER FORCEPS
HNR
Forceps, Ophthalmic
24d
Cleared
Oct 31, 1986
MIRALITE
HQF
Laser, Ophthalmic
70d
Cleared
Oct 31, 1986
THORTON TITANIUM HOOK ANGLED RIGHT
HNQ
Hook, Ophthalmic
17d
Cleared
Oct 31, 1986
THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)
HNC
Specula, Ophthalmic
17d
Cleared
Oct 31, 1986
THORNTON TITANIUM SILVER SPATULA
HND
Spatula, Ophthalmic
17d
Cleared
Oct 31, 1986
THORTON TITANIUM NEEDLEHOLDERS(NO,W CATCH & STAND
HNR
Forceps, Ophthalmic
17d
Cleared
Oct 31, 1986
THORNTON TITANIUM FORCEPS (VARIOUS TYPES)
HNR
Forceps, Ophthalmic
17d
Cleared
Oct 31, 1986
PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS
HNR
Forceps, Ophthalmic
17d
Cleared
Oct 24, 1986
SUNGLASSES (NON-PRESCRIPTION)
HQY
Sunglasses (non-prescription Including Photosensitive)
225d
Cleared
Oct 20, 1986
RK VACUUM FIXATION RING SYSTEM
HNH
Ring, Ophthalmic (flieringa)
24d
Cleared
Oct 16, 1986
BAUSCH & LOMB CLEANING PAD
LPN
Accessories, Soft Lens Products
770d
Cleared
Oct 10, 1986
ENDOPHOTOCOAGULATION PROBE
HQF
Laser, Ophthalmic
25d
Cleared
Oct 10, 1986
OPHTHALMIC FITLER MICRO CAPSULE
HQC
Unit, Phacofragmentation
17d
Cleared
Oct 07, 1986
LDS - LASER DELIVERY SYSTEM
HQF
Laser, Ophthalmic
92d
Cleared
Sep 26, 1986
FORMALENS 2000
HQG
Lens, Spectacle, Non-custom (prescription)
23d
Cleared
Sep 25, 1986
SURGICAL IOP MONITOR
HKX
Tonometer, Ac-powered
35d
Cleared
Sep 24, 1986
MODEL 1000 OPHTHALMIC LASER SYSTEM
HQF
Laser, Ophthalmic
48d
Cleared
Sep 24, 1986
-OM WEST 2000 GNATUS CHAIR
HME
Chair, Ophthalmic, Ac-powered
47d
Cleared
Sep 24, 1986
DIGILAB MODULAR ONE-APPLANATION TONOMETER
HKX
Tonometer, Ac-powered
35d
Cleared
Sep 17, 1986
3M CORNEAL SYSTEM (CORNEAL PRESERVATION MEDIUM)
LYX
Media, Corneal Storage
33d
Cleared
Sep 08, 1986
US PLUS-PAK(R) SURGICAL SYSTEM
HQC
Unit, Phacofragmentation
19d
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