FDA 510(k) Application Details - K230047

Device Classification Name	Laser, Dental, Soft Tissue   More FDA Info for this Device
510(K) Number	K230047
Device Name	Laser, Dental, Soft Tissue
Applicant	Gigaalaser Company Ltd. 304, 306, 3F No.3 plant, Building B10 Wuhan Hi-Tech Medical Device Industrial Park Wuhan 430206 CN Other 510(k) Applications for this Company
Contact	Xinxing Nie 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	01/06/2023
Decision Date	03/04/2024
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