FDA 510(k)

Prismira

K-Number: K243729 · 2025-06-13

Decision Date2025-06-13

Product CodeQFT

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Prismira is the device name listed in this FDA 510(k) record. The listed applicant is Lumos Labs, Inc.. It received FDA 510(k) clearance on 2025-06-13 under 510(k) 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. The listed applicant is Lumos Labs, Inc.. The 510(k) number is K243729.

When did Prismira receive FDA 510(k) clearance?

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

Who is the listed applicant for Prismira?

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

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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