FDA 510(k)

UV Smart D60

Número K: K251354 · 2026-01-29

Data da decisão2026-01-29

Código do produtoSCS

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

UV Smart D60 is the device name listed in this FDA 510(k) record. The listed applicant is UV Smart Technologies B.V.. It received FDA 510(k) clearance on 2026-01-29 under 510(k) number K251354. The device is classified under product code SCS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the UV Smart D60?

UV Smart D60 is a medical device that received FDA 510(k) clearance on 2026-01-29. The listed applicant is UV Smart Technologies B.V.. The 510(k) number is K251354.

When did UV Smart D60 receive FDA 510(k) clearance?

UV Smart D60 received FDA 510(k) clearance on 2026-01-29, under 510(k) number K251354.

Who is the listed applicant for UV Smart D60?

The FDA 510(k) record lists UV Smart Technologies B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UV Smart D60?

The FDA product code for UV Smart D60 is SCS.

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