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
Aug 31, 2020
TrueTear Intranasal Tear Neurostimulator
QBR
Intranasal Electrostimulation Device For Dry Eye Symptoms
252d
Cleared
Aug 21, 2020
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
MVN
Lens, Contact, (disposable)
29d
Cleared
Aug 11, 2020
LION Photocoagulator
HQF
Laser, Ophthalmic
57d
Cleared
Aug 11, 2020
OMNI PLUS Surgical System
MRH
Pump, Infusion, Ophthalmic
28d
Cleared
Aug 06, 2020
Vitra 810
HQF
Laser, Ophthalmic
62d
Cleared
Aug 03, 2020
EyeArt
PIB
Diabetic Retinopathy Detection Device
143d
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
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