FDA 510(k) Application Details - K211265

Device Classification Name	More FDA Info for this Device
510(K) Number	K211265
Device Name	TFX-LT2000 Therapy Light
Applicant	ToeFX, Inc. 1280 Main Street West #039, Ste. B129 Hamilton L8S 4M3 CA Other 510(k) Applications for this Company
Contact	Monika Yazdanian Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2021
Decision Date	11/17/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review