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
2876 Ophthalmic devices
Cleared
Apr 13, 2021
RetCam Envision
HKI
Camera, Ophthalmic, Ac-powered
134d
Cleared
Apr 13, 2021
NFC-600 Automated Portable Retinal Camera
HKI
Camera, Ophthalmic, Ac-powered
78d
Cleared
Apr 12, 2021
Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere
LPL
Lenses, Soft Contact, Daily Wear
59d
Cleared
Apr 09, 2021
Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
HQD
Lens, Contact (other Material) - Daily
123d
Cleared
Apr 07, 2021
CATALYS Precision Laser System
OOE
Ophthalmic Femtosecond Laser
29d
Cleared
Apr 01, 2021
Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo
LPL
Lenses, Soft Contact, Daily Wear
244d
Cleared
Apr 01, 2021
VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System
LYL
Accessories, Solution, Ultrasonic Cleaners For Lenses
57d
Cleared
Mar 12, 2021
VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control
HQC
Unit, Phacofragmentation
155d
Cleared
Mar 11, 2021
Ritleng®+ and Ritleng®+ PVP
OKS
Lacrimal Stents And Intubation Sets
246d
Cleared
Mar 01, 2021
OMNI Surgical System
MRH
Pump, Infusion, Ophthalmic
167d
Not Cleared
Feb 23, 2021
Lumenis Stellar M22
QIU
Intense Pulsed Light Device For Managing Dry Eye
309d
Cleared
Feb 02, 2021
Fundus Camera
HKI
Camera, Ophthalmic, Ac-powered
188d
Cleared
Jan 29, 2021
VX650
HKI
Camera, Ophthalmic, Ac-powered
176d
Cleared
Dec 30, 2020
CryoTreQ
HPS
Unit, Cryophthalmic
160d
Cleared
Dec 24, 2020
Image Quality Analyzer (IQA)
NFJ
System, Image Management, Ophthalmic
308d
Cleared
Dec 18, 2020
LacriJet®
OKS
Lacrimal Stents And Intubation Sets
186d
Cleared
Dec 07, 2020
HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
273d
Cleared
Dec 07, 2020
Ophthalmic Yag Laser System YC-200
HQF
Laser, Ophthalmic
49d
Cleared
Nov 20, 2020
Optomed Smartscope M5 with Optomed Smartscope FA
HKI
Camera, Ophthalmic, Ac-powered
186d
Cleared
Oct 21, 2020
Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
LPL
Lenses, Soft Contact, Daily Wear
162d
Cleared
Oct 21, 2020
Pentacam AXL Wave
MXK
Device, Analysis, Anterior Segment
120d
Cleared
Oct 21, 2020
Iridex 810 Laser
HQF
Laser, Ophthalmic
30d
Cleared
Oct 20, 2020
Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A)
LPL
Lenses, Soft Contact, Daily Wear
29d
Cleared
Oct 15, 2020
xPORT S Lens Fragmentation System
HQC
Unit, Phacofragmentation
261d
Cleared
Oct 15, 2020
Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses
LPL
Lenses, Soft Contact, Daily Wear
252d
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