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FDA 510(k)

Prismira

K-Number: K243729 · 2025-06-13

ApplicantLumos Labs, Inc.
Decision Date2025-06-13
Product CodeQFT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Prismira is a medical device manufactured by Lumos Labs, Inc.. It received FDA 510(k) clearance on 2025-06-13 under approval number K243729. The device is classified under product code QFT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prismira?

Prismira is a medical device that received FDA 510(k) clearance on 2025-06-13. It is manufactured by Lumos Labs, Inc.. The 510(k) number is K243729.

When was Prismira approved by the FDA?

Prismira received FDA 510(k) clearance on 2025-06-13, under approval number K243729.

What company makes Prismira?

Prismira is manufactured by Lumos Labs, Inc..

What is the FDA product code for Prismira?

The FDA product code for Prismira is QFT.

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Official Source

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