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
Nov 25, 1998
OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES)
LPL
Lenses, Soft Contact, Daily Wear
69d
Cleared
Nov 25, 1998
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
MRC
Products, Contact Lens Care, Rigid Gas Permeable
65d
Cleared
Nov 18, 1998
BAUSCH & LOMB PHOENIX (HILAFILCON A) VISIBILITY TINTED CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
15d
Cleared
Nov 17, 1998
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
151d
Cleared
Nov 13, 1998
METROSOFT II, METROSOFT TORIC, METROLITE, METROTINT, SATUREYES, SATUREYES TORIC, SATUREYES LITE, SATUREYES LITE TORIC
LPL
Lenses, Soft Contact, Daily Wear
74d
Cleared
Nov 06, 1998
POLYVUE 43 (OCUFILCON A) SPHERICAL, TORIC AND ASPHERICAL MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR
LPL
Lenses, Soft Contact, Daily Wear
143d
Cleared
Nov 06, 1998
OCU-GUARD AND OCU-GUARD SUPPLE
HQX
Implant, Orbital, Extra-ocular
24d
Cleared
Nov 03, 1998
BAUSCH & LOMB RENU MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
88d
Cleared
Oct 23, 1998
WINSTATION RETINAL IMAGER
HKI
Camera, Ophthalmic, Ac-powered
81d
Cleared
Oct 21, 1998
ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES)
LPL
Lenses, Soft Contact, Daily Wear
50d
Cleared
Sep 18, 1998
RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES
HQX
Implant, Orbital, Extra-ocular
199d
Cleared
Sep 11, 1998
FOAM TIP INJECTOR
MSS
Folders And Injectors, Intraocular Lens (iol)
200d
Cleared
Sep 02, 1998
SOFT (HYDROPHILIC) CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
26d
Cleared
Sep 01, 1998
COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND LUBRICATING AND REWETTING DROPS
LPN
Accessories, Soft Lens Products
153d
Cleared
Sep 01, 1998
ESSTECH MULTI ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
14d
Cleared
Aug 25, 1998
ONE UP DISPOSABLE KERATOME HEAD
HNO
Keratome, Ac-powered
99d
Cleared
Aug 25, 1998
THE WAVE DIGITAL PHACO SYSTEM
HQC
Unit, Phacofragmentation
81d
Cleared
Aug 14, 1998
DISCAM DIGITAL IMAGING SYSTEM
HKI
Camera, Ophthalmic, Ac-powered
255d
Cleared
Aug 14, 1998
FLAPMAKER DISPOSABLE MICROKERATOME
HNO
Keratome, Ac-powered
136d
Cleared
Aug 14, 1998
BC 900 SLIT LAMP
HJO
Biomicroscope, Slit-lamp, Ac-powered
64d
Cleared
Aug 05, 1998
S2LO
HLI
Ophthalmoscope, Ac-powered
89d
Cleared
Aug 04, 1998
ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEAR
HQD
Lens, Contact (other Material) - Daily
196d
Cleared
Aug 04, 1998
V.F.I.-VISCOUS FLUID INFUSION TUBING SET
MRH
Pump, Infusion, Ophthalmic
64d
Cleared
Jul 24, 1998
LIQUID ENZYME ID 90133
LPN
Accessories, Soft Lens Products
84d
Cleared
Jul 24, 1998
CARRIAZO BARRAQUER MICROKERATOME
HMY
Keratome, Battery-powered
67d
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