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
Feb 03, 2011
MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
59d
Cleared
Feb 01, 2011
VISULAS TRION LASER SYSTEM WITH THE VITE OPTION
HQF
Laser, Ophthalmic
109d
Cleared
Jan 26, 2011
KOWA NONMYD WX
HKI
Camera, Ophthalmic, Ac-powered
230d
Cleared
Jan 21, 2011
ENDOSERTER
OTZ
Graft Insertion Instrument For Endothelial Keratoplasty
683d
Cleared
Jan 21, 2011
TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
175d
Cleared
Jan 19, 2011
STERILE SALINE SOLUTION
LPN
Accessories, Soft Lens Products
170d
Cleared
Jan 12, 2011
ISCREEN VISION SCREENER
HKI
Camera, Ophthalmic, Ac-powered
120d
Cleared
Dec 22, 2010
MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE
MSS
Folders And Injectors, Intraocular Lens (iol)
180d
Cleared
Dec 22, 2010
TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM
HKI
Camera, Ophthalmic, Ac-powered
173d
Cleared
Dec 10, 2010
PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000
HKX
Tonometer, Ac-powered
415d
Cleared
Nov 19, 2010
OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
HLJ
Ophthalmoscope, Battery-powered
374d
Cleared
Nov 17, 2010
FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440
HKI
Camera, Ophthalmic, Ac-powered
413d
Cleared
Nov 12, 2010
CONSTELLATION VISION SYSTEM
HQC
Unit, Phacofragmentation
189d
Cleared
Nov 03, 2010
IOLMASTER 500
HJO
Biomicroscope, Slit-lamp, Ac-powered
190d
Cleared
Oct 29, 2010
DIGITAL RETINAL CAMERA
HKI
Camera, Ophthalmic, Ac-powered
105d
Cleared
Oct 28, 2010
METRO SOFT
LPL
Lenses, Soft Contact, Daily Wear
274d
Cleared
Oct 28, 2010
DEFINITIVE, FLEXLENS - SILICONE HYDROGEL
LPL
Lenses, Soft Contact, Daily Wear
253d
Cleared
Oct 28, 2010
CVUE ADVANCED DEFINITIVE
LPL
Lenses, Soft Contact, Daily Wear
253d
Cleared
Oct 27, 2010
CENTERVUE DIGITAL RETINOGRAPHY SYSTEM
HKI
Camera, Ophthalmic, Ac-powered
107d
Cleared
Oct 18, 2010
LENSX LASER SYSTEM
OOE
Ophthalmic Femtosecond Laser
131d
Cleared
Oct 01, 2010
SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA
OBO
Tomography, Optical Coherence
151d
Cleared
Sep 30, 2010
P200MAAF
MYC
Ophthalmoscope, Laser, Scanning
30d
Cleared
Sep 15, 2010
AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION
LPN
Accessories, Soft Lens Products
334d
Cleared
Sep 15, 2010
RTVUE MODEL RTVUE 100
HLI
Ophthalmoscope, Ac-powered
106d
Cleared
Sep 14, 2010
INTELLIWAVE3
LPL
Lenses, Soft Contact, Daily Wear
231d
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