FDA 510(k) Application Details - K242197

Device Classification Name	Light Based Over-The-Counter Hair Removal   More FDA Info for this Device
510(K) Number	K242197
Device Name	Light Based Over-The-Counter Hair Removal
Applicant	Shenzhen Huaruibo Electric Appliances Co., Ltd 3rd Floor, Building A, Chajiaokan Industrial Zone, Sanhe Village, Huarong Community, Dalang Street, Longhua District Shenzhen 518103 CN Other 510(k) Applications for this Company
Contact	Xinhua Luo 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	07/26/2024
Decision Date	10/17/2024
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