FDA 510(k) Application Details - K232885

Device Classification Name	Laser, Dental, Soft Tissue   More FDA Info for this Device
510(K) Number	K232885
Device Name	Laser, Dental, Soft Tissue
Applicant	Shanghai Wonderful Opto-Electrics Tech Co., Ltd. 2F, Building 11, Lane 1175, Tongpu Rd., Putuo District Shanghai 200333 CN Other 510(k) Applications for this Company
Contact	Lily Zhou 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	09/18/2023
Decision Date	02/28/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review