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
Mar 08, 2001
BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT LENS (LATHE-CUT)
LPL
Lenses, Soft Contact, Daily Wear
85d
Cleared
Feb 28, 2001
FLUOROPERM 151-OK, PARAGON HDS 100-OK
MUW
Lens, Contact (orthokeratology)
47d
Cleared
Feb 22, 2001
MEDLOGICS ML 4000, MODEL 4000
HNO
Keratome, Ac-powered
191d
Cleared
Feb 22, 2001
SUTUREGROOVE WEIGHT SIZING SET
MML
Weights, Eyelid, External
87d
Cleared
Feb 21, 2001
COMPLETE BRAND MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
127d
Cleared
Feb 21, 2001
SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
75d
Cleared
Feb 21, 2001
OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
57d
Cleared
Feb 21, 2001
OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT
LPL
Lenses, Soft Contact, Daily Wear
57d
Cleared
Feb 16, 2001
BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY
HQD
Lens, Contact (other Material) - Daily
58d
Cleared
Feb 16, 2001
BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY
MUW
Lens, Contact (orthokeratology)
58d
Cleared
Feb 13, 2001
BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR & BLUE VISIBILITY TINT, LATHE
LPL
Lenses, Soft Contact, Daily Wear
267d
Cleared
Feb 13, 2001
MOJAVE CATARACT EXTRACTION SYSTEM
HQC
Unit, Phacofragmentation
81d
Cleared
Feb 13, 2001
SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
64d
Cleared
Feb 12, 2001
SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY 55 UV MULTIFOCAL (METHAFILCON)
LPL
Lenses, Soft Contact, Daily Wear
88d
Cleared
Feb 08, 2001
LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II
HQC
Unit, Phacofragmentation
86d
Cleared
Feb 08, 2001
FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES
MVN
Lens, Contact, (disposable)
80d
Cleared
Feb 07, 2001
BIO-EYE II ORBITAL IMPLANT
HPZ
Implant, Eye Sphere
105d
Cleared
Jan 25, 2001
WELCH ALLYN 11800 OPTHALMOSCOPE
HLI
Ophthalmoscope, Ac-powered
87d
Cleared
Jan 22, 2001
V/X ASPHERIC TORIC MULTIFOCAL (POLYMACON) SOFT (HYDROPHILIC) LENSES WITH A CLEAR OR BLUE VISIBILITY TINT
LPL
Lenses, Soft Contact, Daily Wear
115d
Cleared
Jan 06, 2001
OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
92d
Cleared
Jan 05, 2001
LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML
LPN
Accessories, Soft Lens Products
99d
Cleared
Jan 05, 2001
MONARCH II IOL DELIVERY SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
30d
Cleared
Jan 04, 2001
PHACOGARD
HQC
Unit, Phacofragmentation
106d
Cleared
Dec 27, 2000
PHACOFRAGMENTATION SYSTEM MEGATRON
HQC
Unit, Phacofragmentation
177d
Cleared
Dec 22, 2000
TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025
KYG
Device, Irrigation, Ocular Surgery
84d
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