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 14, 2003
CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)
LPL
Lenses, Soft Contact, Daily Wear
70d
Cleared
Feb 12, 2003
COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT
HQD
Lens, Contact (other Material) - Daily
57d
Cleared
Feb 05, 2003
GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT CLEAR OR BLUE VISITINT, GELFLEX ALPHA SOFT CONT
LPL
Lenses, Soft Contact, Daily Wear
63d
Cleared
Jan 27, 2003
LID CHAIN EYELID WEIGHTS
MML
Weights, Eyelid, External
244d
Cleared
Jan 24, 2003
MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES
NKX
Needle, Phacoemulsification, Reprocessed
7d
Cleared
Jan 22, 2003
ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER
LPL
Lenses, Soft Contact, Daily Wear
35d
Cleared
Jan 10, 2003
NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
58d
Cleared
Jan 08, 2003
MICROVISION SCLERAL BUCKLING COMPONENTS
HQX
Implant, Orbital, Extra-ocular
83d
Cleared
Dec 26, 2002
MASTEL 1 FOLDER IMPLANTATION SYSTEM
KYB
Lens, Guide, Intraocular
132d
Cleared
Dec 24, 2002
CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)
LPL
Lenses, Soft Contact, Daily Wear
78d
Cleared
Dec 23, 2002
MP-1 MICRO PERIMETER
HKI
Camera, Ophthalmic, Ac-powered
48d
Cleared
Dec 17, 2002
IRIDIS OPHTHALMIC PHOTOCOAGULATOR
HQF
Laser, Ophthalmic
90d
Cleared
Dec 16, 2002
KERATOME BLADE 200200 & 600600
HNO
Keratome, Ac-powered
306d
Cleared
Dec 16, 2002
AUTOLENS CLEANING AND DISINFECTING UNIT
LYL
Accessories, Solution, Ultrasonic Cleaners For Lenses
208d
Cleared
Dec 13, 2002
HA ORBITAL IMPLANT
HPZ
Implant, Eye Sphere
207d
Cleared
Dec 10, 2002
OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT)
LPL
Lenses, Soft Contact, Daily Wear
85d
Cleared
Dec 10, 2002
CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
34d
Cleared
Nov 26, 2002
HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED)
LPL
Lenses, Soft Contact, Daily Wear
36d
Cleared
Nov 26, 2002
CANON FULL AUTO TONOMETER TX-F
HKX
Tonometer, Ac-powered
11d
Cleared
Nov 19, 2002
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
NFJ
System, Image Management, Ophthalmic
377d
Cleared
Nov 19, 2002
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
LYL
Accessories, Solution, Ultrasonic Cleaners For Lenses
98d
Cleared
Nov 15, 2002
MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB
HNO
Keratome, Ac-powered
67d
Cleared
Nov 07, 2002
FUNDUS AUTOIMAGER
HKI
Camera, Ophthalmic, Ac-powered
234d
Cleared
Nov 01, 2002
STEPHENS DISPOSABLE FORCEPS
HNR
Forceps, Ophthalmic
66d
Cleared
Nov 01, 2002
STEPHENS DISPOSABLE SPECULUM
HNC
Specula, Ophthalmic
66d
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