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
Jul 06, 2000
LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA
HQF
Laser, Ophthalmic
24d
Cleared
Jul 03, 2000
OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136
MRC
Products, Contact Lens Care, Rigid Gas Permeable
77d
Cleared
Jun 29, 2000
ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILIT
LPL
Lenses, Soft Contact, Daily Wear
73d
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 19, 2000
OPAQUE HERRICK PLUG, 0.3MM
LZU
Plug, Punctum
12d
Cleared
Jun 14, 2000
AC POWERED THERMAL CAUTERY UNIT
HQO
Unit, Cautery, Thermal, Ac-powered
86d
Cleared
Jun 13, 2000
NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON
NCK
Button, Iris, Eye, Artificial
48d
Cleared
Jun 13, 2000
METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT
LPL
Lenses, Soft Contact, Daily Wear
22d
Cleared
Jun 13, 2000
METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LEN
LPL
Lenses, Soft Contact, Daily Wear
19d
Cleared
Jun 06, 2000
BONASSE CONTACT LENS CASE
LRX
Case, Contact Lens
424d
Cleared
Jun 06, 2000
C.S.O. TONOMETER
HKY
Tonometer, Manual
288d
Cleared
Jun 05, 2000
OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES
LPN
Accessories, Soft Lens Products
74d
Cleared
Jun 02, 2000
COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
135d
Cleared
May 26, 2000
RIGID GAS PERMEABLE CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
74d
Cleared
May 26, 2000
OPTIMUM WETTING AND REWETTING DROP
MRC
Products, Contact Lens Care, Rigid Gas Permeable
21d
Cleared
May 22, 2000
SPORTSIGHT GP
HQD
Lens, Contact (other Material) - Daily
213d
Cleared
May 19, 2000
MENICON Z
HQD
Lens, Contact (other Material) - Daily
122d
Cleared
May 19, 2000
MENICON SF-P
HQD
Lens, Contact (other Material) - Daily
113d
Cleared
May 19, 2000
CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)
NCF
Aberrometer, Ophthalmic
84d
Cleared
May 19, 2000
POLYMACON
LPL
Lenses, Soft Contact, Daily Wear
45d
Cleared
May 19, 2000
METHAFILCON A
LPL
Lenses, Soft Contact, Daily Wear
45d
Cleared
May 15, 2000
SOLO-CARE BRAND HARD SOLUTION
MRC
Products, Contact Lens Care, Rigid Gas Permeable
82d
Cleared
May 12, 2000
HYDRO2, HS-75
HQD
Lens, Contact (other Material) - Daily
88d
Cleared
May 11, 2000
HEADLAMP HL2000.
FSR
Light, Headband, Surgical
136d
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