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 16, 1991
FRAMES (SPECTACLES)
HQZ
Frame, Spectacle
89d
Cleared
Dec 09, 1991
POLLY'S CUTTER J-225
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
90d
Cleared
Dec 09, 1991
PEDIATRIC VITRECTOMY LENS SET
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
90d
Cleared
Dec 04, 1991
DROLITE(TM) LIGHT SOURCE
HJM
Transilluminator, Ac-powered
134d
Cleared
Dec 04, 1991
OPHTHALMIC STAND
HMF
Stand, Instrument, Ac-powered, Ophthalmic
90d
Cleared
Nov 27, 1991
DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM
HKI
Camera, Ophthalmic, Ac-powered
85d
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
Nov 07, 1991
TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM
KYD
Strip, Schirmer
204d
Cleared
Nov 05, 1991
AUTOMATIC CORNEAL SHAPER
HNO
Keratome, Ac-powered
78d
Cleared
Nov 05, 1991
MICROSCIS(TM) INTROCULAR SCISSOR SYSTEM
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
71d
Cleared
Oct 25, 1991
SCOPTOPIC SENSITIVITY TEST-1[SST-1]
HLX
Photostimulator, Ac-powered
38d
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 23, 1991
PROFESSIONAL INDIRECT OPHTHALMOSCOPE
HLI
Ophthalmoscope, Ac-powered
148d
Cleared
Oct 23, 1991
MULTI-VIEW BIFOCALS
HPX
Lens, Contact (polymethylmethacrylate)
107d
Cleared
Oct 23, 1991
ANOMALOSCOPE QUADRANT TEST-6
HIW
Anomaloscope
48d
Cleared
Oct 21, 1991
LOOK VISCODISSECTOR
HQC
Unit, Phacofragmentation
74d
Cleared
Oct 21, 1991
DR. DEAN EDELL SOLARBLOC SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
68d
Cleared
Oct 15, 1991
COLLAGEN SHIELD FOR ACUTE CARE
MOE
Collagen Corneal Shield
91d
Cleared
Oct 15, 1991
NIDEK MODEL NT-1000
HKX
Tonometer, Ac-powered
89d
Cleared
Oct 15, 1991
DUCAL SIDE SHIELD SUNGLASS
HQY
Sunglasses (non-prescription Including Photosensitive)
62d
Cleared
Oct 10, 1991
TURBOTRON 20/20
LYL
Accessories, Solution, Ultrasonic Cleaners For Lenses
464d
Cleared
Oct 09, 1991
CCI VIDEOKERATOSCOPE/COMPARATOR
HLQ
Keratoscope, Ac-powered
92d
Cleared
Oct 09, 1991
GLAUCOMA-SCOPE
HLI
Ophthalmoscope, Ac-powered
86d
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