FDA 510(k) Application Details - K202028

Device Classification Name	Lamp, Infrared, Therapeutic Heating   More FDA Info for this Device
510(K) Number	K202028
Device Name	Lamp, Infrared, Therapeutic Heating
Applicant	Aesthetic Technology Ltd Unit 211 Europa Blvd Warrington WA5 7TN GB Other 510(k) Applications for this Company
Contact	Dale Needham 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	07/22/2020
Decision Date	12/16/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review