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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 K252273
Device Name Therapy US
Applicant
Dmc Importação E Exportação DE Equipamentos Ltda
Rua Sebastião De Moraes, 831 – Jardim Alvorada
São Carlos,  BR 13562425
Applicant Contact Renaldo Massini Junior
Correspondent
Pr Serviços Regulatórios Administrativos Ltda
Edifício Pórtico Sul - R. José Jaime Delibo, 160,
Nova Aliança
Ribeirão Preto,  BR 14026-563
Correspondent Contact Tatiana Jabor Botura
Regulation Number890.5500
Classification Product Code
NHN  
Date Received07/22/2025
Decision Date 12/12/2025
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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