FDA 510(k) Application Details - K223544

Device Classification Name	Light Based Over The Counter Wrinkle Reduction   More FDA Info for this Device
510(K) Number	K223544
Device Name	Light Based Over The Counter Wrinkle Reduction
Applicant	Guangdong Newdermo Biotech Co.,Ltd Building C28. Huachuang Industrial Park, Jinshan Avenue Shiji Town, Panyu Guangzhou 511450 CN Other 510(k) Applications for this Company
Contact	Annie Cai 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	11/25/2022
Decision Date	02/23/2023
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