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 01, 2017
Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor
OBO
Tomography, Optical Coherence
57d
Cleared
Oct 26, 2017
EPI K Console
HNO
Keratome, Ac-powered
29d
Cleared
Oct 25, 2017
AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal
LPL
Lenses, Soft Contact, Daily Wear
56d
Cleared
Oct 24, 2017
ENFLU 18 (enflufocon A) Daily Wear Contact Lens
HQD
Lens, Contact (other Material) - Daily
147d
Cleared
Oct 19, 2017
VICTUS Femtosecond Laser Platform
OOE
Ophthalmic Femtosecond Laser
198d
Cleared
Oct 18, 2017
Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
184d
Cleared
Oct 17, 2017
Applanation tonometer AT-1
HKY
Tonometer, Manual
36d
Cleared
Oct 06, 2017
Digital Eye Anterior Camera
HJO
Biomicroscope, Slit-lamp, Ac-powered
232d
Cleared
Sep 27, 2017
Cetus system, Cetus probe
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
247d
Cleared
Sep 20, 2017
Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)
HQD
Lens, Contact (other Material) - Daily
50d
Cleared
Sep 18, 2017
Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA
LPL
Lenses, Soft Contact, Daily Wear
231d
Cleared
Sep 15, 2017
Phoenix Clinical ICON
HKI
Camera, Ophthalmic, Ac-powered
205d
Cleared
Sep 06, 2017
MicroSTAAR Injector System Cartridges
MSS
Folders And Injectors, Intraocular Lens (iol)
30d
Cleared
Aug 25, 2017
Catalys Precision Laser System
OOE
Ophthalmic Femtosecond Laser
53d
Cleared
Aug 16, 2017
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B)
HQD
Lens, Contact (other Material) - Daily
48d
Cleared
Aug 10, 2017
LENSAR Laser System – fs 3D (LLS-fs 3D)
OOE
Ophthalmic Femtosecond Laser
94d
Cleared
Aug 09, 2017
DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal
LPL
Lenses, Soft Contact, Daily Wear
33d
Cleared
Aug 08, 2017
Ahmed Glaucoma Valve Model FP8
KYF
Implant, Eye Valve
83d
Cleared
Aug 01, 2017
HEXA100 (hexafocon A) Daily Wear Contact Lenses
HQD
Lens, Contact (other Material) - Daily
112d
Cleared
Jul 27, 2017
VISCO 360 Viscosurgical System
MRH
Pump, Infusion, Ophthalmic
31d
Cleared
Jul 25, 2017
Easyret
HQF
Laser, Ophthalmic
197d
Cleared
Jul 21, 2017
Portable Slit Lamp Microscope
HJO
Biomicroscope, Slit-lamp, Ac-powered
294d
Cleared
Jul 17, 2017
BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)
HQD
Lens, Contact (other Material) - Daily
66d
Cleared
Jul 14, 2017
Contact Lens Case
LRX
Case, Contact Lens
49d
Cleared
Jun 27, 2017
Contact Lens Case Round Glasses
LRX
Case, Contact Lens
68d
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