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
May 11, 1998
BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)
HQD
Lens, Contact (other Material) - Daily
74d
Cleared
May 11, 1998
SURGIDEV SILICONE PUNCTUM PLUG
LZU
Plug, Punctum
68d
Cleared
May 06, 1998
NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM
HKI
Camera, Ophthalmic, Ac-powered
103d
Cleared
May 04, 1998
SYNTEC VITMAN
HQC
Unit, Phacofragmentation
90d
Cleared
May 01, 1998
KERATOME BLADE, CHIROM MODEL ALK 500500
HNO
Keratome, Ac-powered
80d
Cleared
May 01, 1998
KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020)
HNO
Keratome, Ac-powered
80d
Cleared
May 01, 1998
SCMD-1000
HNO
Keratome, Ac-powered
45d
Cleared
Apr 30, 1998
PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
87d
Cleared
Apr 30, 1998
PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
87d
Cleared
Apr 30, 1998
SILICONE PUNCTAL PLUG
LZU
Plug, Punctum
85d
Cleared
Apr 24, 1998
KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER
HKI
Camera, Ophthalmic, Ac-powered
85d
Cleared
Apr 22, 1998
MICROKERATOME OR THE MATE
HNO
Keratome, Ac-powered
134d
Cleared
Apr 22, 1998
FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
LPL
Lenses, Soft Contact, Daily Wear
62d
Cleared
Apr 20, 1998
AHMED GLAUCOMA VALVE, MODEL S3
KYF
Implant, Eye Valve
74d
Cleared
Apr 16, 1998
PROCLEAR (OMAFILCON A) DAILY WEAR CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
143d
Cleared
Apr 15, 1998
PLANCON MICROLAMELLAR KERATOME EVOLUTION
HNO
Keratome, Ac-powered
35d
Cleared
Apr 13, 1998
YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION
LPN
Accessories, Soft Lens Products
88d
Cleared
Apr 08, 1998
AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY
MUW
Lens, Contact (orthokeratology)
194d
Cleared
Apr 07, 1998
KEELER TEARSCOPE-PLUS
HJO
Biomicroscope, Slit-lamp, Ac-powered
232d
Cleared
Apr 07, 1998
ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS, TINTED (TRANSPARENT/ENHANCING)
LPL
Lenses, Soft Contact, Daily Wear
53d
Cleared
Mar 31, 1998
PEREGRINE TAPERED DIFFUSION PROBE
MPA
Endoilluminator
85d
Cleared
Mar 31, 1998
PEREGRINE SHIELDED DIFFUSION PROBE
MPA
Endoilluminator
85d
Cleared
Mar 30, 1998
FLOSI RIGID GAS PERMEABLE CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
108d
Cleared
Mar 30, 1998
POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE)
LPL
Lenses, Soft Contact, Daily Wear
27d
Cleared
Mar 23, 1998
METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
66d
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