FDA 510(k) Application Details - K193478

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K193478
Device Name	Powered Laser Surgical Instrument
Applicant	Strata Skin Sciences, Inc. 5 Walnut Grove Drive, Suite 140 Horsham, PA 19044 US Other 510(k) Applications for this Company
Contact	Chuck Mierkiewicz 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	12/16/2019
Decision Date	01/14/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review