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
2877 Ophthalmic devices
Cleared
Jun 02, 2020
Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism
LPL
Lenses, Soft Contact, Daily Wear
92d
Cleared
Jun 02, 2020
MIRA Adapter
HRN
Unit, Cryophthalmic, Ac-powered
57d
Cleared
Jun 01, 2020
XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System
HKI
Camera, Ophthalmic, Ac-powered
182d
Cleared
May 27, 2020
Phacoemulsification Needle (Tip) and Irrigation Sleeve
HQC
Unit, Phacofragmentation
266d
Cleared
May 26, 2020
Aqua Naina Sterile Saline Solution
LPN
Accessories, Soft Lens Products
167d
Cleared
May 21, 2020
Systane iLux2
ORZ
Eyelid Thermal Pulsation System
93d
Cleared
May 18, 2020
Catalys Precision Laser System
OOE
Ophthalmic Femtosecond Laser
126d
Cleared
May 15, 2020
PuriLens Plus Preservative Free Saline
LPN
Accessories, Soft Lens Products
53d
Cleared
May 07, 2020
Icare HOME Tonometer
HKY
Tonometer, Manual
27d
Not Cleared
May 01, 2020
iTEAR Neurostimulator
QKV
Electromechanical Tear Stimulator
352d
Cleared
Apr 27, 2020
Mydriatic Hyperspectral Retinal Camera (MHRC-C1)
HKI
Camera, Ophthalmic, Ac-powered
84d
Cleared
Mar 26, 2020
Konan Specular Microscope XVII
NQE
Microscope, Specular
288d
Cleared
Mar 23, 2020
MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC
LPL
Lenses, Soft Contact, Daily Wear
266d
Cleared
Mar 17, 2020
ACUVUE (senofilcon A) Soft Contact Lens Multifocal
LPL
Lenses, Soft Contact, Daily Wear
46d
Cleared
Mar 16, 2020
CONTINUUM PACS
NFJ
System, Image Management, Ophthalmic
27d
Cleared
Mar 03, 2020
OVision Imaging System
NFJ
System, Image Management, Ophthalmic
28d
Cleared
Mar 02, 2020
Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution
LPN
Accessories, Soft Lens Products
234d
Cleared
Jan 22, 2020
Fundus Camera
HKI
Camera, Ophthalmic, Ac-powered
286d
Cleared
Jan 17, 2020
RxSight Insertion Device
MSS
Folders And Injectors, Intraocular Lens (iol)
93d
Cleared
Jan 14, 2020
Icare ic200
HKY
Tonometer, Manual
335d
Cleared
Jan 14, 2020
MiiS Horus Eye Anterior Camera
HJO
Biomicroscope, Slit-lamp, Ac-powered
57d
Cleared
Dec 23, 2019
MAXReach Laser Probe
HQB
Photocoagulator And Accessories
166d
Cleared
Dec 19, 2019
Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q
HKY
Tonometer, Manual
218d
Cleared
Dec 09, 2019
Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses
LPL
Lenses, Soft Contact, Daily Wear
115d
Cleared
Dec 06, 2019
Intraocular Pressure Tonometer EASYTON
HKX
Tonometer, Ac-powered
290d
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