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 12, 2019
KOWA VK-2s
NFJ
System, Image Management, Ophthalmic
32d
Cleared
Feb 08, 2019
Keeler TonoCare Tonometer
HKX
Tonometer, Ac-powered
283d
Cleared
Feb 06, 2019
DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives
LPL
Lenses, Soft Contact, Daily Wear
28d
Cleared
Jan 30, 2019
Boston Keratoprosthesis, Type I Lucia
HQM
Keratoprosthesis, Permanent Implant
93d
Cleared
Jan 18, 2019
AHMED ClearPath Glaucoma Drainage Device
KYF
Implant, Eye Valve
127d
Cleared
Jan 18, 2019
DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric
LPL
Lenses, Soft Contact, Daily Wear
109d
Cleared
Jan 11, 2019
RESCAN 700, CALLISTO eye
OBO
Tomography, Optical Coherence
350d
Cleared
Jan 10, 2019
CLARUS
QER
Camera, Ophthalmic, Slit-scanning
223d
Cleared
Jan 09, 2019
iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses
MUW
Lens, Contact (orthokeratology)
51d
Cleared
Jan 04, 2019
BostonSight Scleral
HQD
Lens, Contact (other Material) - Daily
49d
Cleared
Jan 02, 2019
NFC-700 non-mydriatic auto fundus camera
HKI
Camera, Ophthalmic, Ac-powered
141d
Cleared
Dec 21, 2018
LENSAR Laser System - fs 3D (LLS-fs 3D)
OOE
Ophthalmic Femtosecond Laser
81d
Cleared
Dec 21, 2018
3nethra neo
HKI
Camera, Ophthalmic, Ac-powered
49d
Cleared
Dec 14, 2018
Tono Vue Non-Contact Tonometer
HKX
Tonometer, Ac-powered
260d
Cleared
Dec 11, 2018
Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker
LPL
Lenses, Soft Contact, Daily Wear
146d
Cleared
Dec 11, 2018
Precision1
LPL
Lenses, Soft Contact, Daily Wear
56d
Cleared
Dec 10, 2018
Applanation tonometer AT-2
HKY
Tonometer, Manual
90d
Cleared
Dec 10, 2018
LipiScan Dynamic Meibomian Imager
HKI
Camera, Ophthalmic, Ac-powered
89d
Cleared
Nov 30, 2018
Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
102d
Cleared
Nov 23, 2018
Hyper GP (tisilfocon A) Daily Wear Contact Lens
HQD
Lens, Contact (other Material) - Daily
91d
Cleared
Nov 22, 2018
Sunkingdom Slit Lamp
HJO
Biomicroscope, Slit-lamp, Ac-powered
90d
Cleared
Nov 21, 2018
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal
LPL
Lenses, Soft Contact, Daily Wear
170d
Cleared
Nov 20, 2018
Orbit Subretinal Delivery System
FMF
Syringe, Piston
90d
Cleared
Nov 13, 2018
Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia
LPL
Lenses, Soft Contact, Daily Wear
48d
Cleared
Nov 09, 2018
Catalys Precision Laser System
OOE
Ophthalmic Femtosecond Laser
99d
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