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 03, 2002
OCULIGHT SL/SLX
HQF
Laser, Ophthalmic
88d
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 26, 2002
OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
53d
Cleared
Apr 25, 2002
PVS BASIC 2
HQD
Lens, Contact (other Material) - Daily
203d
Cleared
Apr 19, 2002
BLADEWORKS MICROKERATOME BLADE, MODEL 7061
HNO
Keratome, Ac-powered
99d
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
Cleared
Apr 03, 2002
AQUIFY LENS COMFORT DROPS
MRC
Products, Contact Lens Care, Rigid Gas Permeable
190d
Cleared
Apr 03, 2002
RIGID GAS PERMEABLE CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
141d
Cleared
Mar 29, 2002
DYNA INTRA-LIMBAL LENS
HQD
Lens, Contact (other Material) - Daily
86d
Cleared
Mar 26, 2002
EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS
KYF
Implant, Eye Valve
214d
Cleared
Mar 11, 2002
VISTITOME 20-10 MICROKERATOME
HNO
Keratome, Ac-powered
97d
Cleared
Mar 04, 2002
MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)
HOQ
Grid, Amsler
87d
Cleared
Mar 04, 2002
STAURENGHI WIDE FIELD SCANNING LASER LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
74d
Cleared
Feb 28, 2002
OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
41d
Cleared
Feb 26, 2002
ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
85d
Cleared
Feb 20, 2002
PORTABLE NON-CONTACT TONOMETER, MODEL PT100
HKX
Tonometer, Ac-powered
142d
Cleared
Feb 20, 2002
COMPLETE BRAND MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
61d
Cleared
Feb 15, 2002
MB 103 MILLENNIUM BLADES
HNO
Keratome, Ac-powered
248d
Cleared
Feb 15, 2002
MB 102 MILLENNIUM BLADES
HNO
Keratome, Ac-powered
32d
Cleared
Feb 11, 2002
COMPLETE BRAND MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
115d
Cleared
Feb 11, 2002
DC-3300 LASER DIODE PHOTOCOAGULATOR
HQF
Laser, Ophthalmic
90d
Cleared
Jan 15, 2002
MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND
MRC
Products, Contact Lens Care, Rigid Gas Permeable
27d
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