FDA 510(k) Application Details - K213554

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K213554
Device Name	Powered Laser Surgical Instrument
Applicant	Sentient Manufacturing LLC 4384 N Forestdale Dr., Suite 202 Park City, UT 84098 US Other 510(k) Applications for this Company
Contact	Jim Mousseau 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	11/08/2021
Decision Date	02/02/2022
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