FDA 510(k) Application Details - K242620

Device Classification Name	Laser, Comb, Hair   More FDA Info for this Device
510(K) Number	K242620
Device Name	Laser, Comb, Hair
Applicant	Shenzhen Breo Technology Co., Ltd. 19/F Hisense Southen Building No.1777 Chuangye Road, Nanshan District Shenzhen 518054 CN Other 510(k) Applications for this Company
Contact	Yong Zhou 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	09/03/2024
Decision Date	11/01/2024
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