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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 the device name listed in this FDA 510(k) record. The listed applicant is Invictus Lighting. It received FDA 510(k) clearance on 2022-05-26 under 510(k) 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. The listed applicant is Invictus Lighting. The 510(k) number is K212644.

When did Aura Storm receive FDA 510(k) clearance?

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

Who is the listed applicant for Aura Storm?

The FDA 510(k) record lists Invictus Lighting as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aura Storm?

The FDA product code for Aura Storm is FRA.

Related Devices (Code: FRA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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