FDA 510(k) Application Details - K231997

Device Classification Name	Lamp, Infrared, Therapeutic Heating   More FDA Info for this Device
510(K) Number	K231997
Device Name	Lamp, Infrared, Therapeutic Heating
Applicant	Cure Point Therapeutics, Inc. 1712 Pioneer Avenue, Suite 2606 Cheyenne, WY 82001 US Other 510(k) Applications for this Company
Contact	Harold Kraft 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	07/05/2023
Decision Date	10/15/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review