FDA 510(k) Application Details - K190542

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K190542
Device Name	Powered Laser Surgical Instrument
Applicant	Soliton Inc. 5304 Ashbrook Drive Houston, TX 77081 US Other 510(k) Applications for this Company
Contact	Leslie Honda 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	03/04/2019
Decision Date	05/24/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review