FDA 510(k) Application Details - K202601

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K202601
Device Name	Powered Laser Surgical Instrument
Applicant	Realton (Suzhou) Medical Technology Co., Ltd 601 Room, B8 Building, 218 Xinghu Road, Suzhou Industrial Park Suzhou 215123 CN Other 510(k) Applications for this Company
Contact	Mingzhu Liu Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	GEX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/2020
Decision Date	12/15/2020
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