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
5110
Total
5092
Cleared
168d
Avg (2y)
1976
Since
2888 Ophthalmic devices
Cleared
Jan 27, 2003
LID CHAIN EYELID WEIGHTS
MML
Weights, Eyelid, External
244d
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 17, 2002
IRIDIS OPHTHALMIC PHOTOCOAGULATOR
HQF
Laser, Ophthalmic
90d
Cleared
Dec 10, 2002
CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
34d
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
Oct 28, 2002
KARATS MULTIPURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
164d
Cleared
Oct 18, 2002
BD K-4000 MICROKERATOME SYSTEM
HMY
Keratome, Battery-powered
30d
Cleared
Oct 18, 2002
ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
NCF
Aberrometer, Ophthalmic
18d
Cleared
Oct 16, 2002
BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME
HMY
Keratome, Battery-powered
69d
Cleared
Oct 03, 2002
DISPOSABLE N-PE MICROKERATOME BLADES
HNO
Keratome, Ac-powered
90d
Cleared
Sep 12, 2002
HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR
HQD
Lens, Contact (other Material) - Daily
87d
Cleared
Aug 22, 2002
BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
52d
Cleared
Aug 05, 2002
MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
HPZ
Implant, Eye Sphere
98d
Cleared
Jul 26, 2002
SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG
LZU
Plug, Punctum
130d
Cleared
Jul 02, 2002
INFINITI
HQC
Unit, Phacofragmentation
50d
Cleared
Jun 27, 2002
SOFT PLUG ABSORBABLE PLUG-SA
LZU
Plug, Punctum
234d
Cleared
Jun 19, 2002
HANSATOME EXCELLUS MICROKERATOME
HNO
Keratome, Ac-powered
30d
Cleared
May 31, 2002
RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION
LYL
Accessories, Solution, Ultrasonic Cleaners For Lenses
80d
Cleared
May 16, 2002
SURGE-FREE ASPIRATION ADAPTER
HQC
Unit, Phacofragmentation
71d
Cleared
May 02, 2002
MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
MRC
Products, Contact Lens Care, Rigid Gas Permeable
41d
Cleared
Apr 29, 2002
MID LABS AUTONOMOUS VIT ENHANCER (AVE)
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
40d
Cleared
Apr 26, 2002
FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
79d
Cleared
Apr 17, 2002
NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000
HKI
Camera, Ophthalmic, Ac-powered
111d
Cleared
Apr 09, 2002
FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN
LPL
Lenses, Soft Contact, Daily Wear
83d
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