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
Apr 27, 1999
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
75d
Cleared
Apr 21, 1999
PVS BASICS
HQD
Lens, Contact (other Material) - Daily
128d
Cleared
Apr 21, 1999
CANTOR & SILVER 5X TINTED (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT WEAR CONTACT LENS, TINTED (TRANSPA
LPL
Lenses, Soft Contact, Daily Wear
44d
Cleared
Apr 20, 1999
FLEXPLUG
LZU
Plug, Punctum
18d
Cleared
Apr 16, 1999
S-38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, THE ESSTECH PS & SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
78d
Cleared
Apr 14, 1999
OXYCON LENS
HQD
Lens, Contact (other Material) - Daily
28d
Cleared
Apr 12, 1999
LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET
MML
Weights, Eyelid, External
77d
Cleared
Apr 04, 1999
DI-RHEX OPHTHALMIC DIATHERMY SYSTEM
HQR
Apparatus, Cautery, Radiofrequency, Ac-powered
86d
Cleared
Apr 02, 1999
SOF-SUCTION FLUID EVACUATION SYSTEM
HOZ
Sponge, Ophthalmic
25d
Cleared
Mar 31, 1999
COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
63d
Cleared
Mar 30, 1999
LPULSA SYL-9000 OPHTHALMIC YAG LASER
HQF
Laser, Ophthalmic
78d
Cleared
Mar 29, 1999
BAUSCH & LOMB RENU EFFERVESCENT ENZYMATIC CONTACT LENS CLEANER
LPN
Accessories, Soft Lens Products
196d
Cleared
Mar 29, 1999
RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCON B) SOFT DAILY WEAR CONTACT LENS, )CLEAR & BLUE VISIBILITY T
LPL
Lenses, Soft Contact, Daily Wear
175d
Cleared
Mar 26, 1999
DIGISCOPE OPHTHALMIC CAMERA
HKI
Camera, Ophthalmic, Ac-powered
64d
Cleared
Mar 25, 1999
KEELER PULSAIR 3000 NON CONTACT TONOMETER
HKX
Tonometer, Ac-powered
57d
Cleared
Mar 15, 1999
TETRAFILCON A
LPL
Lenses, Soft Contact, Daily Wear
20d
Cleared
Mar 05, 1999
ORBSCAN
MXK
Device, Analysis, Anterior Segment
81d
Cleared
Mar 03, 1999
D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
126d
Cleared
Feb 18, 1999
ACTITORIC (OCUFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
162d
Cleared
Feb 16, 1999
THE FREMSTAD RING
HOZ
Sponge, Ophthalmic
204d
Cleared
Feb 16, 1999
FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM
HQC
Unit, Phacofragmentation
90d
Cleared
Feb 16, 1999
IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
57d
Cleared
Feb 11, 1999
RIGID GAS PERMEABLE CONTACT LENS SOLUTION
MRC
Products, Contact Lens Care, Rigid Gas Permeable
104d
Cleared
Feb 11, 1999
LOBOB UNIVERSAL CONTACT LENS CLEANER
LPN
Accessories, Soft Lens Products
36d
Cleared
Feb 03, 1999
EDI VERIS SYSTEM
HLX
Photostimulator, Ac-powered
86d
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