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FDA 510(k)

Aura Storm

K-Number: K212644 · 2022-05-26

ApplicantInvictus Lighting
Decision Date2022-05-26
Product CodeFRA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Aura Storm is a medical device manufactured by Invictus Lighting. It received FDA 510(k) clearance on 2022-05-26 under approval number K212644. The device is classified under product code FRA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aura Storm?

Aura Storm is a medical device that received FDA 510(k) clearance on 2022-05-26. It is manufactured by Invictus Lighting. The 510(k) number is K212644.

When was Aura Storm approved by the FDA?

Aura Storm received FDA 510(k) clearance on 2022-05-26, under approval number K212644.

What company makes Aura Storm?

Aura Storm is manufactured by Invictus Lighting.

What is the FDA product code for Aura Storm?

The FDA product code for Aura Storm is FRA.

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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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