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
5106
Total
5088
Cleared
170d
Avg (2y)
1976
Since
1303 Ophthalmic devices
Cleared
Nov 03, 2010
IOLMASTER 500
HJO
Biomicroscope, Slit-lamp, Ac-powered
190d
Cleared
Aug 17, 2010
STELLARIS PC VISION ENHANCEMENT SYSTEM
HQC
Unit, Phacofragmentation
97d
Cleared
Jul 08, 2010
VISUMAX LASER KERATOME
HQF
Laser, Ophthalmic
161d
Cleared
Mar 09, 2010
PSL CLASSIC SLIT LAMP
HJO
Biomicroscope, Slit-lamp, Ac-powered
15d
Cleared
Jan 05, 2010
BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
244d
Cleared
Nov 18, 2009
BPZ02 MULTIPURPOSE SOLUTION
LYL
Accessories, Solution, Ultrasonic Cleaners For Lenses
336d
Cleared
Apr 14, 2009
CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
165d
Cleared
Mar 23, 2009
DIGITAL RETINAL CAMERA, CR-1 MARK II
HKI
Camera, Ophthalmic, Ac-powered
30d
Cleared
Jan 05, 2009
BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM
HQC
Unit, Phacofragmentation
131d
Cleared
Oct 16, 2008
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
14d
Cleared
Sep 29, 2008
PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR
LPL
Lenses, Soft Contact, Daily Wear
90d
Cleared
Sep 11, 2008
SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS
GEX
Powered Laser Surgical Instrument
86d
Cleared
Aug 28, 2008
BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK
HQC
Unit, Phacofragmentation
30d
Cleared
Jun 10, 2008
SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
MVN
Lens, Contact, (disposable)
85d
Cleared
Apr 24, 2008
CR-1
HKI
Camera, Ophthalmic, Ac-powered
24d
Cleared
Mar 12, 2008
STERILS SINGLE-USE I/A HANDPIECES
HQC
Unit, Phacofragmentation
138d
Cleared
Feb 28, 2008
CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
80d
Cleared
Feb 21, 2008
BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS
HQD
Lens, Contact (other Material) - Daily
100d
Cleared
Jan 24, 2008
CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
118d
Cleared
Jan 04, 2008
AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
192d
Cleared
Nov 05, 2007
NEXT GENERATION LASER
HQF
Laser, Ophthalmic
426d
Cleared
Aug 15, 2007
BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
100d
Cleared
Aug 02, 2007
BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES
HQD
Lens, Contact (other Material) - Daily
112d
Cleared
Mar 19, 2007
REPROCESSED PHACOEMULSIFICATION TIPS
NKX
Needle, Phacoemulsification, Reprocessed
371d
Cleared
Mar 07, 2007
AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28
KYB
Lens, Guide, Intraocular
84d
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