FDA 510(k) Application Details - K213889

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K213889
Device Name	Powered Laser Surgical Instrument
Applicant	Asclepion Laser Technologies GmbH Bruesseler Strasse 10 Jena 07747 DE Other 510(k) Applications for this Company
Contact	Carolin Kuehling 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	12/13/2021
Decision Date	04/22/2022
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