FDA 510(k)

PHAROS

Número K: K250170 · 2025-08-15

Data da decisão2025-08-15

Código do produtoKPS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

PHAROS is the device name listed in this FDA 510(k) record. The listed applicant is Brightonix Imaging. It received FDA 510(k) clearance on 2025-08-15 under 510(k) number K250170. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PHAROS?

PHAROS is a medical device that received FDA 510(k) clearance on 2025-08-15. The listed applicant is Brightonix Imaging. The 510(k) number is K250170.

When did PHAROS receive FDA 510(k) clearance?

PHAROS received FDA 510(k) clearance on 2025-08-15, under 510(k) number K250170.

Who is the listed applicant for PHAROS?

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

What is the FDA product code for PHAROS?

The FDA product code for PHAROS is KPS.

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Dispositivos Relacionados (Código: KPS)

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