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FDA 510(k)

Nova HD+

K-Number: K220938 · 2023-08-22

ApplicantAura Wellness, LLC
Decision Date2023-08-22
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Nova HD+ is a medical device manufactured by Aura Wellness, LLC. It received FDA 510(k) clearance on 2023-08-22 under approval number K220938. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nova HD+?

Nova HD+ is a medical device that received FDA 510(k) clearance on 2023-08-22. It is manufactured by Aura Wellness, LLC. The 510(k) number is K220938.

When was Nova HD+ approved by the FDA?

Nova HD+ received FDA 510(k) clearance on 2023-08-22, under approval number K220938.

What company makes Nova HD+?

Nova HD+ is manufactured by Aura Wellness, LLC.

What is the FDA product code for Nova HD+?

The FDA product code for Nova HD+ is NGX.

Other Devices by Aura Wellness, LLC

K250896Aura Wave

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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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