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FDA 510(k)

OPXION Optical Skin Viewer (OPXSV1-01F)

K-Number: K242924 · 2025-06-23

ApplicantOpxion Technology, Inc.
Decision Date2025-06-23
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Opxion Technology, Inc.. The 510(k) number is K242924.

When was OPXION Optical Skin Viewer (OPXSV1-01F) approved by the FDA?

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

What company makes OPXION Optical Skin Viewer (OPXSV1-01F)?

OPXION Optical Skin Viewer (OPXSV1-01F) is manufactured by Opxion Technology, Inc..

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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Official Source

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