FDA 510(k) Application Details - K091420

Device Classification Name	Powered Laser Surgical Instrument With Microbeam\Fractional Output   More FDA Info for this Device
510(K) Number	K091420
Device Name	Powered Laser Surgical Instrument With Microbeam\Fractional Output
Applicant	SOLTA MEDICAL, INC. 25881 INDUSTRIAL BLVD. HAYWOOD, CA 94043-2991 US Other 510(k) Applications for this Company
Contact	HEATHER MACFALLS 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	05/13/2009
Decision Date	10/14/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review