FDA 510(k) Application Details - K242440

Device Classification Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect   More FDA Info for this Device
510(K) Number	K242440
Device Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant	Nanjing Bestview Laser S&T Co., Ltd. 1st & 2nd Floor, Building 5, Area 1, Phase 2 Liandong U Valley Science and Technology Innovation Park Nanjing 210000 CN Other 510(k) Applications for this Company
Contact	Jing Wang Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	ONF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2024
Decision Date	11/14/2024
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