FDA 510(k) Application Details - K242755

Device Classification Name	Lamp, Infrared, Therapeutic Heating   More FDA Info for this Device
510(K) Number	K242755
Device Name	Lamp, Infrared, Therapeutic Heating
Applicant	Gigaalaser Company Ltd. B15-8F, Wuhan Hi-Tech Medical device park, #818 Gaoxin Road Wuhan CN Other 510(k) Applications for this Company
Contact	Xinxing Nie 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	09/12/2024
Decision Date	05/19/2025
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