FDA 510(k) Application Details - K250253

Device Classification Name	Light Based Over-The-Counter Hair Removal   More FDA Info for this Device
510(K) Number	K250253
Device Name	Light Based Over-The-Counter Hair Removal
Applicant	Dongguan Boyuan Intelligent Technology Co.,Ltd Room 801,Building 3, No.3 Kuiqiao Road, Puxin Lake, Tangxia Town Dongguan 523719 CN Other 510(k) Applications for this Company
Contact	JinLong Li Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	OHT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/28/2025
Decision Date	05/06/2025
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