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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
510(k) Number K232813
Device Name Therapy EC, Therapy XT
Applicant
Dmc Importacao E Exportacao DE Equipamentos Ltda
Sebastiao De Moraes - 831
Sao Carlos,  BR 13562030
Applicant Contact Renata Beninca Pereira
Correspondent
Pr Servicos Regulatorios Administrativos Ltda
Rua Alice Alem Saadi, 855/2402
Ribeirao Preto,  BR 14096570
Correspondent Contact Homero Santiago Antunes
Regulation Number890.5500
Classification Product Code
NHN  
Date Received09/13/2023
Decision Date 12/19/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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