TFX-LT2000 Therapy Light

Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

ToeFX, Inc.

The following data is part of a premarket notification filed by Toefx, Inc. with the FDA for Tfx-lt2000 Therapy Light.

Pre-market Notification Details

Device IDK211265
510k NumberK211265
Device Name:TFX-LT2000 Therapy Light
ClassificationLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Applicant ToeFX, Inc. 1280 Main Street West #039, Ste. B129 Hamilton,  CA L8S 4M3
ContactMonika Yazdanian
CorrespondentAlexander Braun Henderson
BraunSolutions Regulatory Group 970 South Dawson Way Unit 14 Aurora,  CO  80012
Product CodePDZ  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-26
Decision Date2022-11-17

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