FDA 510(k) Application Details - K041565

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	K041565
Device Name	Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Applicant	LED HEALING LIGHT LLC 1276 CHAMBERS ROAD AURORA, CO 80017 US Other 510(k) Applications for this Company
Contact	MICHAEL B KINDER 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	06/10/2004
Decision Date	03/03/2005
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