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
Feb 04, 1986
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
60d
Cleared
Feb 04, 1986
MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS
HQF
Laser, Ophthalmic
56d
Cleared
Feb 04, 1986
OPTRONICS CONTRAST ACUITY TESTER
HOX
Chart, Visual Acuity
54d
Cleared
Feb 04, 1986
BARTELL SMALL INCISION LENS GLIDE
KYB
Lens, Guide, Intraocular
54d
Cleared
Feb 04, 1986
BARRAQUER-KRUMEICH REFRACTIVE SET
HNO
Keratome, Ac-powered
33d
Cleared
Jan 22, 1986
IOSERT LENS IMPLANT INSTRUMENT
KYB
Lens, Guide, Intraocular
99d
Cleared
Dec 31, 1985
CSM MEDIUM
LYX
Media, Corneal Storage
89d
Cleared
Dec 30, 1985
THE NEW MOBILE TIP MCINTYRE CANNULA
HMX
Cannula, Ophthalmic
60d
Cleared
Dec 30, 1985
THE NEW MCINTYRE I.A. HANDPIECE
HMX
Cannula, Ophthalmic
60d
Cleared
Dec 30, 1985
KEELER-COMPACT CRYO SYSTEM
HQA
Unit, Cryotherapy, Ophthalmic
59d
Cleared
Dec 30, 1985
SERIES 25 SLIMLINE CRYO PROBES
HQA
Unit, Cryotherapy, Ophthalmic
56d
Cleared
Dec 30, 1985
LECTROSTILL DISTILLED WATER U.S.P.
33d
Cleared
Dec 27, 1985
PLACIDO DISC
HLR
Keratoscope, Battery-powered
85d
Cleared
Dec 27, 1985
PHACO PACKS, 1A PACKS & PACK COMPONENTS
HQC
Unit, Phacofragmentation
80d
Cleared
Dec 27, 1985
ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS
HQC
Unit, Phacofragmentation
70d
Cleared
Dec 27, 1985
COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR
HQC
Unit, Phacofragmentation
58d
Cleared
Dec 19, 1985
O.M.S. ULTRA-PHACO
HQC
Unit, Phacofragmentation
401d
Cleared
Dec 17, 1985
MODIFIED MYDRIATIC SPECTACLE
68d
Cleared
Dec 16, 1985
STORZ IAS DISPOSABLE PACK
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
123d
Cleared
Dec 16, 1985
ALL-IN-ONE HARD CONTACT LENS SOLUTION
HPX
Lens, Contact (polymethylmethacrylate)
96d
Cleared
Dec 16, 1985
WETTING SOLUTION FOR HARD CONTACT LENSES
HPX
Lens, Contact (polymethylmethacrylate)
96d
Cleared
Dec 16, 1985
HARD CONTACT LENS SOAKING SOLUTION
HPX
Lens, Contact (polymethylmethacrylate)
96d
Cleared
Dec 16, 1985
PUPILSCAN
62d
Cleared
Dec 13, 1985
HESSBURG LIGHT GUARD
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
148d
Cleared
Dec 13, 1985
700-123 EYE SHADE
HQY
Sunglasses (non-prescription Including Photosensitive)
147d
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