FDA 510(k) Application Details - K250425

Device Classification Name	Light, Ultraviolet, Dermatological   More FDA Info for this Device
510(K) Number	K250425
Device Name	Light, Ultraviolet, Dermatological
Applicant	APK Technology Co., Ltd. 6 Floor, Building B2, Industry of Hengfeng, No. 739, Zhoushi Hezhou, Hangcheng Street, BaoÆan District Shenzhen 518100 CN Other 510(k) Applications for this Company
Contact	Caifang Wang 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	02/14/2025
Decision Date	04/07/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review