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FDA 510(k)

Aura Wave

K-Number: K250896 · 2025-12-02

ApplicantAura Wellness, LLC
Decision Date2025-12-02
Product CodeSGT
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Aura Wave is the device name listed in this FDA 510(k) record. The listed applicant is Aura Wellness, LLC. It received FDA 510(k) clearance on 2025-12-02 under 510(k) number K250896. The device is classified under product code SGT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aura Wave?

Aura Wave is a medical device that received FDA 510(k) clearance on 2025-12-02. The listed applicant is Aura Wellness, LLC. The 510(k) number is K250896.

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

Aura Wave received FDA 510(k) clearance on 2025-12-02, under 510(k) number K250896.

Who is the listed applicant for Aura Wave?

The FDA 510(k) record lists Aura Wellness, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aura Wave?

The FDA product code for Aura Wave is SGT.

Other records listing Aura Wellness, LLC as applicant

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

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

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