FDA 510(k) Application Details - K214008

Device Classification Name	Laser, Dental, Soft Tissue   More FDA Info for this Device
510(K) Number	K214008
Device Name	Laser, Dental, Soft Tissue
Applicant	Shenzhen Soga Technology Co., Ltd. D906, Yinxing Technology Building No. 1301, Sightseeing Road Xinlan Community, Guanlan Street, Longhua District Shenzhen 518110 CN Other 510(k) Applications for this Company
Contact	Tse Adrian Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	NVK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2021
Decision Date	05/10/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review