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FDA 510(k)

LUMYS (V1)

K-Number: K243069 · 2025-05-02

ApplicantIntradys
Decision Date2025-05-02
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LUMYS (V1) is a medical device manufactured by Intradys. It received FDA 510(k) clearance on 2025-05-02 under approval number K243069. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMYS (V1)?

LUMYS (V1) is a medical device that received FDA 510(k) clearance on 2025-05-02. It is manufactured by Intradys. The 510(k) number is K243069.

When was LUMYS (V1) approved by the FDA?

LUMYS (V1) received FDA 510(k) clearance on 2025-05-02, under approval number K243069.

What company makes LUMYS (V1)?

LUMYS (V1) is manufactured by Intradys.

What is the FDA product code for LUMYS (V1)?

The FDA product code for LUMYS (V1) is LLZ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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