FDA 510(k) Application Details - K081166

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	K081166
Device Name	Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Applicant	SOLICA CORPORATION 129 YORKVILLE AVENUE SUITE 300 TORONTO, ONTARIO M5R 1C4 CA Other 510(k) Applications for this Company
Contact	CARLA WINSLOW 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	04/24/2008
Decision Date	04/03/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review