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
5100
Total
5082
Cleared
170d
Avg (2y)
1976
Since
492 Ophthalmic devices
Cleared
Mar 29, 2019
BL-Cart IOL Delivery Cartridge
MSS
Folders And Injectors, Intraocular Lens (iol)
155d
Cleared
Mar 26, 2019
WaveLight FS200 Patient Interface
GEX
Powered Laser Surgical Instrument
35d
Cleared
Mar 06, 2019
VISULAS green
HQF
Laser, Ophthalmic
253d
Cleared
Mar 05, 2019
ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)
LPL
Lenses, Soft Contact, Daily Wear
256d
Cleared
Feb 15, 2019
CIRRUS HD-OCT
OBO
Tomography, Optical Coherence
249d
Cleared
Feb 12, 2019
Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens
HQD
Lens, Contact (other Material) - Daily
89d
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
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