FDA 510(k) Application Details - K101490

Device Classification Name	Powered Laser Surgical Instrument With Microbeam\Fractional Output   More FDA Info for this Device
510(K) Number	K101490
Device Name	Powered Laser Surgical Instrument With Microbeam\Fractional Output
Applicant	THERMAGE, INC. 25881 INDUSTRIAL BLVD. HAYWARD, CA 94545 US Other 510(k) Applications for this Company
Contact	KRISS FOSS 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	06/01/2010
Decision Date	09/08/2010
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