FDA 510(k)

Avéli

K-Number: K232153 · 2023-08-18

Decision Date2023-08-18

Product CodeOUP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Avéli is the device name listed in this FDA 510(k) record. The listed applicant is Revelle Aesthetics, Inc.. It received FDA 510(k) clearance on 2023-08-18 under 510(k) number K232153. The device is classified under product code OUP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Avéli?

Avéli is a medical device that received FDA 510(k) clearance on 2023-08-18. The listed applicant is Revelle Aesthetics, Inc.. The 510(k) number is K232153.

When did Avéli receive FDA 510(k) clearance?

Avéli received FDA 510(k) clearance on 2023-08-18, under 510(k) number K232153.

Who is the listed applicant for Avéli?

The FDA 510(k) record lists Revelle Aesthetics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Avéli?

The FDA product code for Avéli is OUP.

Other records listing Revelle Aesthetics, Inc. 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.

K221336Avéli

Related Devices (Code: OUP)

K221336AvéliRevelle Aesthetics, Inc.K212399AveliNc8, Inc.K192185The Cellfina SystemUlthera, Inc.K161885The Cellfina SystemUlthera, Inc.K153677The Cellfina SystemUlthera, Inc.

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.