FDA 510(k) Application Details - K213025

Device Classification Name	Laser, Comb, Hair   More FDA Info for this Device
510(K) Number	K213025
Device Name	Laser, Comb, Hair
Applicant	Kam Yuen Plastic Products Ltd. No. 2, Hengfeng 2nd Road, Pujin Industrial, Konghou Town Zhongshan 528400 CN Other 510(k) Applications for this Company
Contact	Anna Dan Other 510(k) Applications for this Contact
Regulation Number	890.5500   More FDA Info for this Regulation Number
Classification Product Code	OAP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/21/2021
Decision Date	05/12/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review