FDA 510(k) Application Details - K221189

Device Classification Name	Lamp, Infrared, Therapeutic Heating   More FDA Info for this Device
510(K) Number	K221189
Device Name	Lamp, Infrared, Therapeutic Heating
Applicant	LTBIO Co., Ltd. 1058, B-dong, Seongnam SKV1 Tower, 14, Galmachi-ro 288beon-gil, Jungwon-gu Seongnam-si 13201 KR Other 510(k) Applications for this Company
Contact	Min-Ho Kim 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	04/25/2022
Decision Date	08/29/2022
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