FDA 510(k) Application Details - K242908

Device Classification Name	Light, Ultraviolet, Dermatological   More FDA Info for this Device
510(K) Number	K242908
Device Name	Light, Ultraviolet, Dermatological
Applicant	Shanghai SIGMA High-tech Co., Ltd. The West Wing, 1st FL., Building No.7&The East Wing, 11th FL Building No.8, No.388 Shuanglian Road, Xujing Town, Qingpu D Shanghai CN Other 510(k) Applications for this Company
Contact	Xing Guo 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	09/24/2024
Decision Date	12/19/2024
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