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 a medical device manufactured by Aura Wellness, LLC. It received FDA 510(k) clearance on 2025-12-02 under approval 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. It is manufactured by Aura Wellness, LLC. The 510(k) number is K250896.
When was Aura Wave approved by the FDA?
Aura Wave received FDA 510(k) clearance on 2025-12-02, under approval number K250896.
What company makes Aura Wave?
Aura Wave is manufactured by Aura Wellness, LLC.
What is the FDA product code for Aura Wave?
The FDA product code for Aura Wave is SGT.
Other Devices by Aura Wellness, LLC
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.