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
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
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
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