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FDA 510(k)

OrthoPulse 2.0E (OPi2E-100)

Número K: K230905 · 2023-06-09

RequerenteBiolux Technology GmbH
Data da decisão2023-06-09
Código do produtoPLH
Comité consultivoDE
DecisãoSubstantially Equivalent

Resumo do dispositivo

OrthoPulse 2.0E (OPi2E-100) is the device name listed in this FDA 510(k) record. The listed applicant is Biolux Technology GmbH. It received FDA 510(k) clearance on 2023-06-09 under 510(k) number K230905. The device is classified under product code PLH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OrthoPulse 2.0E (OPi2E-100)?

OrthoPulse 2.0E (OPi2E-100) is a medical device that received FDA 510(k) clearance on 2023-06-09. The listed applicant is Biolux Technology GmbH. The 510(k) number is K230905.

When did OrthoPulse 2.0E (OPi2E-100) receive FDA 510(k) clearance?

OrthoPulse 2.0E (OPi2E-100) received FDA 510(k) clearance on 2023-06-09, under 510(k) number K230905.

Who is the listed applicant for OrthoPulse 2.0E (OPi2E-100)?

The FDA 510(k) record lists Biolux Technology GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OrthoPulse 2.0E (OPi2E-100)?

The FDA product code for OrthoPulse 2.0E (OPi2E-100) is PLH.

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