FDA 510(k) Application Details - K131903

Device Classification Name	Powered Laser Surgical Instrument With Microbeam\Fractional Output   More FDA Info for this Device
510(K) Number	K131903
Device Name	Powered Laser Surgical Instrument With Microbeam\Fractional Output
Applicant	ECLIPSE AESTHETICS, LLC 13988 Diplomat Dr Suite 160 Dallas, TX 75234 US Other 510(k) Applications for this Company
Contact	TOM O'BRIEN Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	ONG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2013
Decision Date	09/19/2013
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