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 16, 2000
MSP M/K BLADE
HNO
Keratome, Ac-powered
178d
Cleared
Mar 15, 2000
ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
HNO
Keratome, Ac-powered
110d
Cleared
Mar 09, 2000
BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080
HJX
Reader, Prism, Ophthalmic
20d
Cleared
Mar 06, 2000
FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX
LPL
Lenses, Soft Contact, Daily Wear
28d
Cleared
Mar 03, 2000
BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
87d
Cleared
Mar 02, 2000
HYLASHIELD CL
MRC
Products, Contact Lens Care, Rigid Gas Permeable
83d
Cleared
Feb 23, 2000
VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
LPL
Lenses, Soft Contact, Daily Wear
63d
Cleared
Feb 23, 2000
ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
LPL
Lenses, Soft Contact, Daily Wear
63d
Cleared
Feb 22, 2000
CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION
LYL
Accessories, Solution, Ultrasonic Cleaners For Lenses
88d
Cleared
Feb 10, 2000
ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS)
HNO
Keratome, Ac-powered
140d
Cleared
Feb 02, 2000
EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEAR
HQD
Lens, Contact (other Material) - Daily
167d
Cleared
Feb 02, 2000
SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
103d
Cleared
Jan 31, 2000
ULTRASHAPER KERATOME
HNO
Keratome, Ac-powered
371d
Cleared
Jan 20, 2000
CAUTERY GRASPER/DISSECTOR
HQP
Unit, Cautery, Thermal, Battery-powered
55d
Cleared
Jan 10, 2000
AUTOMATED OPHTHALMICS SOFTIPS
HKY
Tonometer, Manual
125d
Cleared
Jan 07, 2000
VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)
MRH
Pump, Infusion, Ophthalmic
119d
Cleared
Jan 05, 2000
SOLO-CARE BRAND HARD SOLUTION
MRC
Products, Contact Lens Care, Rigid Gas Permeable
44d
Cleared
Jan 04, 2000
TUBING EXTENSION SET
MSR
Tubing, Replacement, Phacofragmentation Unit
90d
Cleared
Dec 28, 1999
BLADEWORKS DISPOSABLE ALK TUBING
KYG
Device, Irrigation, Ocular Surgery
67d
Cleared
Dec 22, 1999
PARAGON LENS CARRIER
LRX
Case, Contact Lens
68d
Cleared
Dec 22, 1999
PARAGON LENS VIAL
LRX
Case, Contact Lens
68d
Cleared
Dec 21, 1999
KEELER CRYO MASTER & PROBES
HRN
Unit, Cryophthalmic, Ac-powered
111d
Cleared
Dec 21, 1999
M-PACT CORNEAL LIGHT SHIELD
HOZ
Sponge, Ophthalmic
36d
Cleared
Dec 21, 1999
DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI
LPL
Lenses, Soft Contact, Daily Wear
32d
Cleared
Dec 10, 1999
ACTIFRESH 400 LENS
LPL
Lenses, Soft Contact, Daily Wear
420d
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