FDA 510(k) Application Details - K192617

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K192617
Device Name	Powered Laser Surgical Instrument
Applicant	Azena Medical, LLC 3021 Citrus Circle Ste 180 Walnut Creek, CA 94598 US Other 510(k) Applications for this Company
Contact	Lindsay Tilton 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	09/23/2019
Decision Date	02/20/2020
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