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
Jul 13, 2016
OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)
MUW
Lens, Contact (orthokeratology)
106d
Cleared
Jul 13, 2016
PolyDev Soft Contact Lenses
LPL
Lenses, Soft Contact, Daily Wear
97d
Cleared
Jul 06, 2016
Easy-Load Lens Delivery System
MSS
Folders And Injectors, Intraocular Lens (iol)
86d
Cleared
Jun 22, 2016
Portable Slit Lamp
HJO
Biomicroscope, Slit-lamp, Ac-powered
194d
Cleared
Jun 15, 2016
LightLas Multi-Wavelength Medical Laser System
HQF
Laser, Ophthalmic
271d
Cleared
Jun 08, 2016
MAIA
MYC
Ophthalmoscope, Laser, Scanning
218d
Not Cleared
Jun 08, 2016
PEDIATRIC VISION SCANNER
PMW
Strabismus Detection Device
908d
Cleared
Jun 07, 2016
Contact Lens Case (multiple brand name)
LRX
Case, Contact Lens
155d
Cleared
Jun 06, 2016
MICROPERIMETER MP-3
HKI
Camera, Ophthalmic, Ac-powered
258d
Cleared
May 26, 2016
Z5 Slit lamp microscope, Z2 Slit lamp microscope
HJO
Biomicroscope, Slit-lamp, Ac-powered
265d
Cleared
May 26, 2016
Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016
LPL
Lenses, Soft Contact, Daily Wear
108d
Cleared
May 17, 2016
SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
244d
Cleared
May 13, 2016
Oasis Lacrimal Intubation Set
OKS
Lacrimal Stents And Intubation Sets
59d
Cleared
May 12, 2016
LSFG-NAVI
HKI
Camera, Ophthalmic, Ac-powered
185d
Cleared
May 11, 2016
Slit Lamp Microscope
HJO
Biomicroscope, Slit-lamp, Ac-powered
259d
Cleared
May 06, 2016
Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor
OBO
Tomography, Optical Coherence
274d
Cleared
May 02, 2016
Green Laser Photocoagulator GYC-500
HQF
Laser, Ophthalmic
234d
Cleared
May 02, 2016
AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric
LPL
Lenses, Soft Contact, Daily Wear
60d
Cleared
Apr 29, 2016
Bi-Blade Vitrectomy Cutter
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
179d
Cleared
Apr 27, 2016
EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES
HQD
Lens, Contact (other Material) - Daily
218d
Cleared
Apr 27, 2016
Dual Pump Pack
HQC
Unit, Phacofragmentation
86d
Not Cleared
Apr 20, 2016
GLAUCOMA COMPANION
PLX
Tear Duct Occluder
642d
Cleared
Apr 19, 2016
Icare ic100
HKY
Tonometer, Manual
118d
Cleared
Apr 15, 2016
Applanation Tonometer
HKY
Tonometer, Manual
610d
Cleared
Apr 08, 2016
EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear
LPL
Lenses, Soft Contact, Daily Wear
144d
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