FDA 510(k) Application Details - K221151

Device Classification Name	Light Based Over The Counter Wrinkle Reduction   More FDA Info for this Device
510(K) Number	K221151
Device Name	Light Based Over The Counter Wrinkle Reduction
Applicant	Hunan Guangye Biotechnology Co., Ltd. Room 701, Jinhong Park Incubation Building, No.229, Tongzipo West Road, High-tech Development Changsha City 410006 CN Other 510(k) Applications for this Company
Contact	Eileen Li Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	OHS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2022
Decision Date	07/19/2022
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