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
Jul 01, 1992
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
131d
Cleared
Jun 30, 1992
IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USE
HQC
Unit, Phacofragmentation
88d
Cleared
Jun 25, 1992
SUNGLASSES AND EYEGLASS FRAMES
HQY
Sunglasses (non-prescription Including Photosensitive)
127d
Cleared
Jun 23, 1992
BREATH-EASY, MODIFICATION
HME
Chair, Ophthalmic, Ac-powered
272d
Cleared
Jun 19, 1992
KERATOREF L60
HLQ
Keratoscope, Ac-powered
49d
Cleared
Jun 11, 1992
MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM
HQC
Unit, Phacofragmentation
345d
Cleared
Jun 11, 1992
OPHTHALMIC PROJECTOR
HOS
Projector, Ophthalmic
90d
Cleared
Jun 09, 1992
STERILE/SINGLE USE OPHTHALMIC CONFORMERS
HQN
Conformer, Ophthalmic
88d
Cleared
Jun 09, 1992
DEXSOL CORNEAL STORAGE MEDIA CONTAINER, MODIFIED
LYX
Media, Corneal Storage
76d
Cleared
Jun 09, 1992
OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIED
LYX
Media, Corneal Storage
76d
Cleared
Jun 03, 1992
IOLAB POWER I.V. POLE
HQC
Unit, Phacofragmentation
85d
Cleared
May 18, 1992
DISPOSABLE POSTERIOR MICROSCISSORS
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
90d
Cleared
May 08, 1992
180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
88d
Cleared
May 07, 1992
TRIAL LENS SET
HPC
Set, Lens, Trial, Ophthalmic
90d
Cleared
May 07, 1992
ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION
HMX
Cannula, Ophthalmic
38d
Cleared
May 01, 1992
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
109d
Cleared
May 01, 1992
SUN/SPORTGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
106d
Cleared
Apr 21, 1992
WEINSTEIN CORNEAL MIRCOAESTHESIOMETER
HJC
Esthesiometer, Ocular
90d
Cleared
Apr 21, 1992
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
89d
Cleared
Apr 15, 1992
OPTICAL FRAME A285, A210, B220, A215, A255, B220,
HQZ
Frame, Spectacle
91d
Cleared
Mar 31, 1992
CABLE CAR SUNGLASSES
HQZ
Frame, Spectacle
146d
Cleared
Mar 30, 1992
MENTOR HORIZON LOW VISION MAGNIFIER
HJG
System, Reading, Television, Closed-circuit
158d
Cleared
Mar 30, 1992
STERILE/SINGLE USE EYE SPHERE IMPLANTS
HPZ
Implant, Eye Sphere
21d
Cleared
Mar 25, 1992
SUNGLASSES/READING GLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
127d
Cleared
Mar 19, 1992
AQUEOUS PARACENTESIS PIPET
KYG
Device, Irrigation, Ocular Surgery
86d
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