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
Jun 10, 2008
SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
MVN
Lens, Contact, (disposable)
85d
Cleared
Jun 03, 2008
FALCK APPLANATION TONOMETER (FAT2)
HKY
Tonometer, Manual
341d
Cleared
May 30, 2008
SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS
HQD
Lens, Contact (other Material) - Daily
49d
Cleared
May 09, 2008
ALCON VISION SYSTEM
HQC
Unit, Phacofragmentation
526d
Cleared
May 06, 2008
OPHTHALMOSCOPE F-10
MYC
Ophthalmoscope, Laser, Scanning
266d
Cleared
Apr 24, 2008
CR-1
HKI
Camera, Ophthalmic, Ac-powered
24d
Cleared
Apr 22, 2008
WESTCON HORIZON 49% (HIOXIFILCON B)
LPL
Lenses, Soft Contact, Daily Wear
42d
Cleared
Apr 04, 2008
KOWA GENESIS-D
HKI
Camera, Ophthalmic, Ac-powered
25d
Cleared
Mar 19, 2008
DURETTE IMPLANT
HPZ
Implant, Eye Sphere
117d
Cleared
Mar 13, 2008
MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
84d
Cleared
Mar 13, 2008
MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
84d
Cleared
Mar 12, 2008
STERILS SINGLE-USE I/A HANDPIECES
HQC
Unit, Phacofragmentation
138d
Cleared
Mar 11, 2008
INTEGRE, MODEL LP581
HQF
Laser, Ophthalmic
25d
Cleared
Mar 05, 2008
SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR
HQD
Lens, Contact (other Material) - Daily
40d
Cleared
Mar 03, 2008
VISTAKON (NARAFILCON) A SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
82d
Cleared
Feb 28, 2008
CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES
LPL
Lenses, Soft Contact, Daily Wear
80d
Cleared
Feb 27, 2008
SOCT COPERNICUS, MODEL 15205
OBO
Tomography, Optical Coherence
237d
Cleared
Feb 22, 2008
NONCON ROBO PACHY F&A
NQE
Microscope, Specular
525d
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 11, 2008
SLIT LAMP
HJO
Biomicroscope, Slit-lamp, Ac-powered
59d
Cleared
Jan 04, 2008
AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
192d
Cleared
Dec 21, 2007
LIFE4C
LYX
Media, Corneal Storage
415d
Cleared
Dec 14, 2007
MERILAS 532A
HQF
Laser, Ophthalmic
73d
Cleared
Dec 12, 2007
ALCON MULTI-PURPOSE SOLUTION
LPN
Accessories, Soft Lens Products
223d
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