FDA 510(k) Application Details - K100213

Device Classification Name	Lamp, Infrared, Therapeutic Heating   More FDA Info for this Device
510(K) Number	K100213
Device Name	Lamp, Infrared, Therapeutic Heating
Applicant	LUMANOSITY, INC 11271 VENTURA BLVD SUITE 212 STUDIO CITY, CA 91604 US Other 510(k) Applications for this Company
Contact	JEFF PROVISSIERO Other 510(k) Applications for this Contact
Regulation Number	890.5500   More FDA Info for this Regulation Number
Classification Product Code	ILY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/25/2010
Decision Date	10/04/2010
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