FDA 510(k) Application Details - K211534

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K211534
Device Name	Powered Laser Surgical Instrument
Applicant	LISA Laser Products GmbH Albert-Einstein-Str, 4 Katlenburg-Lindau 37191 DE Other 510(k) Applications for this Company
Contact	Ralf Balkenhol 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	05/18/2021
Decision Date	05/19/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review