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
Aug 03, 2020
Glaucoma Module
NFJ
System, Image Management, Ophthalmic
116d
Cleared
Jul 31, 2020
xPORT 304 (miCOR) System Lens Fragmentation System
HQC
Unit, Phacofragmentation
147d
Cleared
Jul 31, 2020
VibrantVue Scleral Saline
MRC
Products, Contact Lens Care, Rigid Gas Permeable
100d
Cleared
Jul 23, 2020
Canon non-mydriatic retinal camera CR series
HKI
Camera, Ophthalmic, Ac-powered
87d
Cleared
Jul 15, 2020
Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
84d
Cleared
Jul 14, 2020
Orbit Subretinal Delivery System
FMF
Syringe, Piston
155d
Cleared
Jun 17, 2020
Miru 1day UpSide (midafilcon A)
LPL
Lenses, Soft Contact, Daily Wear
194d
Cleared
Jun 15, 2020
Visalis V500, Visalis S500
HQC
Unit, Phacofragmentation
193d
Cleared
Jun 04, 2020
bioli lOL Delivery System
MSS
Folders And Injectors, Intraocular Lens (iol)
143d
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
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