FDA 510(k) Application Details - K192642

Device Classification Name	Light, Ultraviolet, Dermatological   More FDA Info for this Device
510(K) Number	K192642
Device Name	Light, Ultraviolet, Dermatological
Applicant	Chongqing Peninsula Medical Technology Co., Ltd. No.2-4, 2F Block I, Ke Yuan 4th Road, Jiulongpo District Chongqing 400041 CN Other 510(k) Applications for this Company
Contact	Zhang Sudi Other 510(k) Applications for this Contact
Regulation Number	878.4630   More FDA Info for this Regulation Number
Classification Product Code	FTC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2019
Decision Date	05/13/2020
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