FDA 510(k) Application Details - K242068

Device Classification Name	Over-The-Counter Powered Light Based Laser For Acne   More FDA Info for this Device
510(K) Number	K242068
Device Name	Over-The-Counter Powered Light Based Laser For Acne
Applicant	Ningbo Dechang Electrical Machinery Made Co.,Ltd No.18 YongXing East Road ,Dongjiao Industrial District YuYao 315400 CN Other 510(k) Applications for this Company
Contact	Yinling Liu Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	OLP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/15/2024
Decision Date	04/04/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review