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 21, 2011
INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE
HQC
Unit, Phacofragmentation
90d
Cleared
Nov 08, 2011
CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A)
LPL
Lenses, Soft Contact, Daily Wear
188d
Cleared
Nov 08, 2011
SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)
OBO
Tomography, Optical Coherence
15d
Cleared
Nov 07, 2011
LAMINAR FLOW PHACO TIPS
HQC
Unit, Phacofragmentation
129d
Cleared
Nov 03, 2011
LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM
HQF
Laser, Ophthalmic
336d
Cleared
Nov 03, 2011
OPTO MITRA YELLOW LASER
HQF
Laser, Ophthalmic
143d
Cleared
Nov 02, 2011
BIOCERAMIC ORBITAL IMPLANT, ORBTEX
HPZ
Implant, Eye Sphere
247d
Cleared
Nov 02, 2011
SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
173d
Cleared
Nov 01, 2011
EYE-CEPT STERILE SALINE SOLUTION
LPN
Accessories, Soft Lens Products
280d
Cleared
Oct 28, 2011
EASYSCAN MODEL 1.2
MYC
Ophthalmoscope, Laser, Scanning
107d
Cleared
Oct 25, 2011
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
MVN
Lens, Contact, (disposable)
88d
Cleared
Oct 19, 2011
TBD
OOE
Ophthalmic Femtosecond Laser
89d
Cleared
Oct 17, 2011
27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA
HQB
Photocoagulator And Accessories
196d
Cleared
Oct 13, 2011
MONARCH III IOL DELIVERY SYSTEM
MSS
Folders And Injectors, Intraocular Lens (iol)
476d
Cleared
Sep 27, 2011
AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM
HQC
Unit, Phacofragmentation
102d
Cleared
Sep 20, 2011
FULL AUTO TONOMETER MODEL TX-20
HKX
Tonometer, Ac-powered
92d
Cleared
Sep 15, 2011
PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC
LPL
Lenses, Soft Contact, Daily Wear
66d
Cleared
Sep 15, 2011
SILICONE SPHERES
HPZ
Implant, Eye Sphere
49d
Cleared
Sep 14, 2011
DIGITAL RETINAL CAMERA
HKI
Camera, Ophthalmic, Ac-powered
97d
Cleared
Sep 08, 2011
FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI
LPL
Lenses, Soft Contact, Daily Wear
318d
Cleared
Sep 08, 2011
RTVUE CAM WITH CORNEAL POWER UPGRADE
OBO
Tomography, Optical Coherence
100d
Cleared
Aug 30, 2011
RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION
HJO
Biomicroscope, Slit-lamp, Ac-powered
224d
Cleared
Aug 19, 2011
P200T
MYC
Ophthalmoscope, Laser, Scanning
70d
Cleared
Aug 11, 2011
PASCAL STREAMLINE 577 (WITH ACCESSORIES)
HQF
Laser, Ophthalmic
113d
Cleared
Jul 28, 2011
ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS
LPL
Lenses, Soft Contact, Daily Wear
181d
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