FDA 510(k) Application Details - K113097

Device Classification Name	Laser, Comb, Hair   More FDA Info for this Device
510(K) Number	K113097
Device Name	Laser, Comb, Hair
Applicant	THERADOME INC. 1001 BEAR ISLAND RD, SUITE 136 SUMMERVILLE, SC 29483 US Other 510(k) Applications for this Company
Contact	LARRY PETERSEN Other 510(k) Applications for this Contact
Regulation Number	890.5500   More FDA Info for this Regulation Number
Classification Product Code	OAP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/19/2011
Decision Date	03/02/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review