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
Mar 26, 2001
AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION
LPN
Accessories, Soft Lens Products
152d
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 09, 2001
OPD-SCAN, MODELS ARK-10000 AND ARK-9000
HLQ
Keratoscope, Ac-powered
140d
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
Cleared
Feb 21, 2001
COMPLETE BRAND MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
127d
Cleared
Feb 13, 2001
MOJAVE CATARACT EXTRACTION SYSTEM
HQC
Unit, Phacofragmentation
81d
Cleared
Jan 25, 2001
WELCH ALLYN 11800 OPTHALMOSCOPE
HLI
Ophthalmoscope, Ac-powered
87d
Cleared
Jan 05, 2001
MONARCH II IOL DELIVERY SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
30d
Cleared
Dec 13, 2000
GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
72d
Cleared
Dec 11, 2000
MODEL 30 CLASSIC PNEUMATONOMETER
HKX
Tonometer, Ac-powered
126d
Cleared
Nov 21, 2000
COMPLETE BRAND LUBRICATING AND REWETTING DROPS
LPN
Accessories, Soft Lens Products
48d
Cleared
Oct 31, 2000
CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1
MSS
Folders And Injectors, Intraocular Lens (iol)
75d
Cleared
Oct 20, 2000
VISIJET HYDROKERATOME, MODEL 50
MYD
Keratome, Water Jet
567d
Cleared
Oct 20, 2000
CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES
NCZ
Lens, Contact, For Color Vision Deficiency
303d
Cleared
Oct 18, 2000
PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES
HNO
Keratome, Ac-powered
35d
Cleared
Oct 17, 2000
RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION
LPN
Accessories, Soft Lens Products
36d
Cleared
Oct 10, 2000
MENICON PROGENT REMOVER
MRC
Products, Contact Lens Care, Rigid Gas Permeable
85d
Cleared
Sep 21, 2000
DISPOSABLE MICROKERATOME BLADES-PE
HNO
Keratome, Ac-powered
163d
Cleared
Sep 20, 2000
CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ
HLI
Ophthalmoscope, Ac-powered
272d
Cleared
Sep 13, 2000
METHAFILCON A
LPL
Lenses, Soft Contact, Daily Wear
21d
Cleared
Jul 31, 2000
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
75d
Cleared
Jun 27, 2000
MONARCH II IOL DELIVERY SYSTEM
KYB
Lens, Guide, Intraocular
78d
Cleared
Jun 21, 2000
CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100
HLI
Ophthalmoscope, Ac-powered
323d
Cleared
Jun 06, 2000
BONASSE CONTACT LENS CASE
LRX
Case, Contact Lens
424d
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