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
2889 Ophthalmic devices
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
Cleared
Dec 10, 1999
VIT ENHANCER
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
101d
Cleared
Nov 24, 1999
OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
141d
Cleared
Nov 24, 1999
METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP
MVN
Lens, Contact, (disposable)
57d
Cleared
Nov 19, 1999
I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
294d
Cleared
Nov 18, 1999
COLORMAX COLOR VISION ENHANCEMENT LENSES
NAI
Lens, Prescription, Color Deficiency
358d
Cleared
Nov 18, 1999
CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS
LPL
Lenses, Soft Contact, Daily Wear
78d
Cleared
Nov 16, 1999
RICROKERATOME BLADE
HNO
Keratome, Ac-powered
74d
Cleared
Nov 09, 1999
SL990, SL980, SL950
HJO
Biomicroscope, Slit-lamp, Ac-powered
78d
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