FDA 510(k) Application Details - K161565

Device Classification Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect   More FDA Info for this Device
510(K) Number	K161565
Device Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant	STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD 10-11th Floor, Bensi Building, New High-Tech-Park, Ganli Village, Buji District Shenzhen CN Other 510(k) Applications for this Company
Contact	Juan Ye Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	ONF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/2016
Decision Date	09/01/2016
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