FDA 510(k) Application Details - K232813

Device Classification Name	Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy   More FDA Info for this Device
510(K) Number	K232813
Device Name	Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Applicant	DMC Importacao e Exportacao de Equipamentos LTDA Sebastiao de Moraes - 831 Sao Carlos 13562030 BR Other 510(k) Applications for this Company
Contact	Renata Beninca Pereira Other 510(k) Applications for this Contact
Regulation Number	890.5500   More FDA Info for this Regulation Number
Classification Product Code	NHN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/13/2023
Decision Date	12/19/2024
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