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
Dec 22, 2000
PEDIATRIC INGESTASCAN
HPM
Locator, Metal, Electronic
63d
Cleared
Dec 18, 2000
MEGAVISION CPX, MEGAVISION FA, MODEL I AND II
HKI
Camera, Ophthalmic, Ac-powered
90d
Cleared
Dec 15, 2000
ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT
LPL
Lenses, Soft Contact, Daily Wear
66d
Cleared
Dec 15, 2000
RYTHMIC AND RYTHMIC UV
LPL
Lenses, Soft Contact, Daily Wear
66d
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
Dec 11, 2000
MILLENNIUM BLADES, MODEL MB101
HNO
Keratome, Ac-powered
62d
Cleared
Dec 08, 2000
PAFLUFOCON C AND E DAILY CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
87d
Cleared
Nov 29, 2000
A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5
HQC
Unit, Phacofragmentation
65d
Cleared
Nov 21, 2000
O-PERM 30
HQD
Lens, Contact (other Material) - Daily
83d
Cleared
Nov 21, 2000
SPECIALTY TINT SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
49d
Cleared
Nov 21, 2000
COMPLETE BRAND LUBRICATING AND REWETTING DROPS
LPN
Accessories, Soft Lens Products
48d
Cleared
Nov 08, 2000
IRIS RETRACTING PHACOEMULSIFICATION SLEEVE
HQC
Unit, Phacofragmentation
61d
Cleared
Nov 08, 2000
OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
47d
Cleared
Nov 02, 2000
RETINADX
HKI
Camera, Ophthalmic, Ac-powered
16d
Cleared
Oct 31, 2000
RIGID GAS PERMEABLE CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
120d
Cleared
Oct 31, 2000
CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1
MSS
Folders And Injectors, Intraocular Lens (iol)
75d
Cleared
Oct 23, 2000
THERMAL CAUTERY UNIT, MODEL 150
HQO
Unit, Cautery, Thermal, Ac-powered
83d
Cleared
Oct 23, 2000
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
LPN
Accessories, Soft Lens Products
63d
Cleared
Oct 20, 2000
STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR
HQP
Unit, Cautery, Thermal, Battery-powered
64d
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
SMARTLENS
HKX
Tonometer, Ac-powered
64d
Cleared
Oct 18, 2000
PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES
HNO
Keratome, Ac-powered
35d
Cleared
Oct 17, 2000
INSIGHT 4000 ENDOSCOPE
MPA
Endoilluminator
264d
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