FDA 510(k) Application Details - K182173

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K182173
Device Name	Powered Laser Surgical Instrument
Applicant	Sciton, Inc 925 Commercial Street Palo Alto, CA 94303 US Other 510(k) Applications for this Company
Contact	Jay M. Patel 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	08/10/2018
Decision Date	03/06/2019
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