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
5110
Total
5092
Cleared
168d
Avg (2y)
1976
Since
2883 Ophthalmic devices
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
Cleared
Apr 08, 2016
Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear
LPL
Lenses, Soft Contact, Daily Wear
100d
Cleared
Mar 28, 2016
ACUVUE (senofilcon C) Soft Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
59d
Cleared
Mar 17, 2016
Specular Microscope CEM- 530
NQE
Microscope, Specular
267d
Cleared
Mar 04, 2016
SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
241d
Not Cleared
Mar 04, 2016
SENSIMED TRIGGERFISH
PLZ
Ocular Pattern Recorder
668d
Cleared
Feb 11, 2016
Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist
LPL
Lenses, Soft Contact, Daily Wear
213d
Cleared
Feb 11, 2016
RTVue XR OCT Avanti with AngioVue Software
HLI
Ophthalmoscope, Ac-powered
111d
Cleared
Feb 09, 2016
BostonSight IC Corneal Lens, BostonSight IC Scleral Lens
HQD
Lens, Contact (other Material) - Daily
110d
Cleared
Jan 20, 2016
Pentacam AXL
MXK
Device, Analysis, Anterior Segment
159d
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