FDA 510(k) Application Details - K181868

Device Classification Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect   More FDA Info for this Device
510(K) Number	K181868
Device Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant	IDS, Ltd. #105, Byoksan Digital Valley 3 cha 271, Digital-ro, Guro-gu Seoul 08381 KR Other 510(k) Applications for this Company
Contact	C.J. Park 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	07/12/2018
Decision Date	10/05/2018
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