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
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
Cleared
Sep 25, 2020
ImageSPECTRUM
NFJ
System, Image Management, Ophthalmic
136d
Not Cleared
Sep 24, 2020
Tangible Boost
QMM
Hydrophilic Re-coating Solution
255d
Cleared
Sep 23, 2020
Boston One Step Liquid Enzymatic Cleaner
MRC
Products, Contact Lens Care, Rigid Gas Permeable
216d
Cleared
Sep 22, 2020
DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
MVN
Lens, Contact, (disposable)
27d
Cleared
Sep 18, 2020
Optixon 1-Day
LPL
Lenses, Soft Contact, Daily Wear
154d
Cleared
Sep 10, 2020
RxSight Contact Lens
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
63d
Cleared
Sep 09, 2020
Spectralis HRA+OCT and variants
OBO
Tomography, Optical Coherence
121d
Cleared
Sep 08, 2020
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
HQD
Lens, Contact (other Material) - Daily
127d
Cleared
Sep 02, 2020
OCT-Camera ID 21101A3
OBO
Tomography, Optical Coherence
184d
Cleared
Sep 01, 2020
VICTUS Femtosecond Laser Platform
OOE
Ophthalmic Femtosecond Laser
166d
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