FDA 510(k) Application Details - K191693

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K191693
Device Name	Powered Laser Surgical Instrument
Applicant	Reveallux, Corp 4508 38th, Suite 230 Columbus, NE 68601 US Other 510(k) Applications for this Company
Contact	Justin D Linn 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	06/25/2019
Decision Date	11/01/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review