FDA 510(k)

OPXION Optical Skin Viewer (OPXSV1-01F)

Número K: K242924 · 2025-06-23

Data da decisão2025-06-23

Código do produtoNQQ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

OPXION Optical Skin Viewer (OPXSV1-01F) is the device name listed in this FDA 510(k) record. The listed applicant is Opxion Technology, Inc.. It received FDA 510(k) clearance on 2025-06-23 under 510(k) number K242924. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OPXION Optical Skin Viewer (OPXSV1-01F)?

OPXION Optical Skin Viewer (OPXSV1-01F) is a medical device that received FDA 510(k) clearance on 2025-06-23. The listed applicant is Opxion Technology, Inc.. The 510(k) number is K242924.

When did OPXION Optical Skin Viewer (OPXSV1-01F) receive FDA 510(k) clearance?

OPXION Optical Skin Viewer (OPXSV1-01F) received FDA 510(k) clearance on 2025-06-23, under 510(k) number K242924.

Who is the listed applicant for OPXION Optical Skin Viewer (OPXSV1-01F)?

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

What is the FDA product code for OPXION Optical Skin Viewer (OPXSV1-01F)?

The FDA product code for OPXION Optical Skin Viewer (OPXSV1-01F) is NQQ.

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