FDA 510(k) Application Details - K243764

Device Classification Name	Laser, Dental, Soft Tissue   More FDA Info for this Device
510(K) Number	K243764
Device Name	Laser, Dental, Soft Tissue
Applicant	Wuhan Pioon Technology Co., Ltd. 12th Fl, Bldg 1, Innovative Unit, R&D Center Project,Marine World Shipyard Pk,No. 16 Fozuling 3rd Rd, East Lake High Wuhan 430205 CN Other 510(k) Applications for this Company
Contact	Feng Zhang 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	12/06/2024
Decision Date	05/08/2025
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