FDA 510(k) Application Details - K230739

Device Classification Name	Light Based Over-The-Counter Hair Removal   More FDA Info for this Device
510(K) Number	K230739
Device Name	Light Based Over-The-Counter Hair Removal
Applicant	Shenzhen IONKA Medical Technology Co., Ltd. Room 601, No. 3, Jiazitang Second Industrial Zone, Jiazitang Community, Fenghuang Street, Guang Shenzhen 518132 CN Other 510(k) Applications for this Company
Contact	Chen Dongfa 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	03/17/2023
Decision Date	05/26/2023
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