FDA 510(k) Application Details - K080513

Device Classification Name	Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy   More FDA Info for this Device
510(K) Number	K080513
Device Name	Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Applicant	2035, INC. 13 RED FOX LANE LITTLETON, CO 80127 US Other 510(k) Applications for this Company
Contact	Kevin Walls Other 510(k) Applications for this Contact
Regulation Number	890.5500   More FDA Info for this Regulation Number
Classification Product Code	NHN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/25/2008
Decision Date	01/30/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review