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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
510(k) Number K211265
Device Name TFX-LT2000 Therapy Light
Applicant
Toefx, Inc.
1280 Main St. W. #039, Suite B129
Hamilton,  CA L8S 4M3
Applicant Contact Monika Yazdanian
Correspondent
Braunsolutions Regulatory Group
970 S. Dawson Way Unit 14
Aurora,  CO  80012
Correspondent Contact Alexander Braun Henderson
Regulation Number878.4810
Classification Product Code
PDZ  
Date Received04/26/2021
Decision Date 11/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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