FDA 510(k) Application Details - K170068

Device Classification Name	Lamp, Infrared, Therapeutic Heating   More FDA Info for this Device
510(K) Number	K170068
Device Name	Lamp, Infrared, Therapeutic Heating
Applicant	WELLRAY MEDICAL LASER, INC. 216 Moores Run Rd. Wardensville, WV 26851 US Other 510(k) Applications for this Company
Contact	Richard O DeRoberts 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	01/09/2017
Decision Date	05/05/2017
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