FDA 510(k) Application Details - K213056

Device Classification Name	Over-The-Counter Powered Light Based Laser For Acne   More FDA Info for this Device
510(K) Number	K213056
Device Name	Over-The-Counter Powered Light Based Laser For Acne
Applicant	Shenzhen OSTO Technology Company Limited No.43 Longfeng Road, Xinsheng Community, Longgang Street Longgang District Shenzhen 518100 CN Other 510(k) Applications for this Company
Contact	Li Yang 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	09/22/2021
Decision Date	07/07/2022
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