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
2899 Ophthalmic devices
Cleared
Jan 23, 1992
CANDELA RETINAL CAMERA
HKI
Camera, Ophthalmic, Ac-powered
182d
Cleared
Jan 06, 1992
LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE
HLI
Ophthalmoscope, Ac-powered
90d
Cleared
Dec 27, 1991
PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE
HQC
Unit, Phacofragmentation
44d
Cleared
Dec 24, 1991
DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
210d
Cleared
Dec 23, 1991
ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)
HLI
Ophthalmoscope, Ac-powered
194d
Cleared
Dec 18, 1991
SOFTRANS INJECTOR
HQL
Intraocular Lens
125d
Cleared
Dec 17, 1991
PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE
HQC
Unit, Phacofragmentation
168d
Cleared
Dec 09, 1991
PEDIATRIC VITRECTOMY LENS SET
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
90d
Cleared
Nov 13, 1991
LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
61d
Cleared
Nov 13, 1991
SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS
MOE
Collagen Corneal Shield
33d
Cleared
Oct 25, 1991
KPE 230 AM
HQC
Unit, Phacofragmentation
60d
Cleared
Oct 25, 1991
KPE 220 TS, NONSTERILE
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
63d
Cleared
Oct 21, 1991
LOOK VISCODISSECTOR
HQC
Unit, Phacofragmentation
74d
Cleared
Oct 15, 1991
NIDEK MODEL NT-1000
HKX
Tonometer, Ac-powered
89d
Cleared
Oct 02, 1991
EYE BUBBLE
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
126d
Cleared
Oct 02, 1991
UNIDIRECTIONAL OCCLUDER
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
72d
Cleared
Aug 28, 1991
SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE
HQC
Unit, Phacofragmentation
68d
Cleared
Aug 21, 1991
LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS
MLP
Keratoprosthesis, Temporary Implant, Surgical Use
175d
Cleared
Aug 12, 1991
PMT METAL LOCATOR, MODEL 3630-1
HPM
Locator, Metal, Electronic
105d
Cleared
Aug 09, 1991
TBD KERATOSCOPE
HLQ
Keratoscope, Ac-powered
87d
Cleared
Aug 07, 1991
LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
78d
Cleared
Aug 07, 1991
LANDERS NOTCHED VITRECTOMY LENS RING
HNH
Ring, Ophthalmic (flieringa)
77d
Cleared
Aug 07, 1991
LANDERS NOTCHED IRRIGATING VITRECTOMY LENS RING
HNH
Ring, Ophthalmic (flieringa)
77d
Cleared
Jul 25, 1991
TBD, LENS MEASURING DEVICE
HRJ
Table, Instrument, Powered, Ophthalmic
72d
Cleared
Jul 25, 1991
LANDERS THREE STRUT VITRECTOMY LENS RING
HNH
Ring, Ophthalmic (flieringa)
71d
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