FDA 510(k) Application Details - K213830

Device Classification Name	Light Based Over-The-Counter Hair Removal   More FDA Info for this Device
510(K) Number	K213830
Device Name	Light Based Over-The-Counter Hair Removal
Applicant	Iluminage Beauty Co., Limited Level 54, Hopewell Centre, 183 Queen's Road East Wan Chai 999077 HK Other 510(k) Applications for this Company
Contact	Jacky Lee 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	12/08/2021
Decision Date	02/01/2022
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