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
Jun 19, 2001
OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S
LPL
Lenses, Soft Contact, Daily Wear
28d
Cleared
Jun 13, 2001
BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L
LPL
Lenses, Soft Contact, Daily Wear
51d
Cleared
Jun 13, 2001
BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING T
LPL
Lenses, Soft Contact, Daily Wear
44d
Cleared
Jun 01, 2001
ISCREEN VISION SCREENER
HKI
Camera, Ophthalmic, Ac-powered
119d
Cleared
May 23, 2001
POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS)
LPL
Lenses, Soft Contact, Daily Wear
145d
Cleared
May 23, 2001
SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALITY 42 UV TORIC (HEFILCON A) SOFT C
LPL
Lenses, Soft Contact, Daily Wear
43d
Cleared
May 04, 2001
MODIFICATION TO EDI VERIS SYSTEM
HLX
Photostimulator, Ac-powered
179d
Cleared
May 02, 2001
WEISS RETINAL CANNULA
HMX
Cannula, Ophthalmic
90d
Cleared
May 02, 2001
KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010
MML
Weights, Eyelid, External
20d
Cleared
Apr 27, 2001
HANSATOME MICROKERATOME
HNO
Keratome, Ac-powered
88d
Cleared
Apr 27, 2001
MED-LOGICS DISPOSABLE ALK TUBING
KYG
Device, Irrigation, Ocular Surgery
80d
Cleared
Apr 13, 2001
PRESCOTT'S SURGICAL SPEAR
HOZ
Sponge, Ophthalmic
122d
Cleared
Apr 12, 2001
VISTAKON (METHAFILCON A) CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
50d
Cleared
Apr 11, 2001
ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR)
LPL
Lenses, Soft Contact, Daily Wear
85d
Cleared
Mar 26, 2001
AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION
LPN
Accessories, Soft Lens Products
152d
Cleared
Mar 26, 2001
ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBIL
LPL
Lenses, Soft Contact, Daily Wear
56d
Cleared
Mar 23, 2001
FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT
MVN
Lens, Contact, (disposable)
18d
Cleared
Mar 16, 2001
VISTAKON (HEFILCON C) CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
51d
Cleared
Mar 16, 2001
BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT)
LPL
Lenses, Soft Contact, Daily Wear
51d
Cleared
Mar 12, 2001
D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
61d
Cleared
Mar 12, 2001
PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
LPL
Lenses, Soft Contact, Daily Wear
55d
Cleared
Mar 09, 2001
OPD-SCAN, MODELS ARK-10000 AND ARK-9000
HLQ
Keratoscope, Ac-powered
140d
Cleared
Mar 09, 2001
CARRIAZO BARRAQUER SINGLE USE MICROKERATOME
HMY
Keratome, Battery-powered
108d
Cleared
Mar 08, 2001
DISPOSABLE CB-PE MICROKERATOME BLADES
HNO
Keratome, Ac-powered
87d
Cleared
Mar 08, 2001
FOCUS DAILIES PROGRESSIVES
MVN
Lens, Contact, (disposable)
87d
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