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
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
Cleared
Jan 20, 2016
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal
LPL
Lenses, Soft Contact, Daily Wear
30d
Cleared
Jan 20, 2016
Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
LPL
Lenses, Soft Contact, Daily Wear
30d
Cleared
Jan 15, 2016
Falck Medical Multifunction Tonometer, FAT1
HKY
Tonometer, Manual
226d
Cleared
Jan 14, 2016
LipiView II Ocular Surface Interferometer
HKI
Camera, Ophthalmic, Ac-powered
106d
Cleared
Dec 31, 2015
KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100
HKY
Tonometer, Manual
106d
Cleared
Dec 24, 2015
BrainPort V100
PIC
Oral Electronic Vision Aid
86d
Cleared
Dec 17, 2015
Molteno3 Glaucoma Implant
KYF
Implant, Eye Valve
65d
Cleared
Dec 02, 2015
EnFocus 2300, EnFocus 4400
HLI
Ophthalmoscope, Ac-powered
257d
Cleared
Nov 24, 2015
Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)
LPL
Lenses, Soft Contact, Daily Wear
124d
Cleared
Oct 30, 2015
MicroSTAAR Injector System Cartridges
KYB
Lens, Guide, Intraocular
71d
Cleared
Oct 23, 2015
FEMTO LDV Z8 Surgical Laser
OOE
Ophthalmic Femtosecond Laser
256d
Cleared
Oct 19, 2015
AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control
HQC
Unit, Phacofragmentation
124d
Cleared
Oct 15, 2015
LENSAR Laser System - fs 3D (LLS-fs 3D)
OOE
Ophthalmic Femtosecond Laser
48d
Cleared
Oct 13, 2015
Sensor Medical Single Use Tonometer Prism
HKY
Tonometer, Manual
60d
Cleared
Oct 02, 2015
ARGOS
MXK
Device, Analysis, Anterior Segment
193d
Cleared
Oct 01, 2015
Synergy ODM
NFJ
System, Image Management, Ophthalmic
78d
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