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FDA 510(k)

Cleo

K-Number: K232011 · 2023-07-07

ApplicantAmerican Orthodontics
Decision Date2023-07-07
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Cleo is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 2023-07-07 under 510(k) number K232011. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cleo?

Cleo is a medical device that received FDA 510(k) clearance on 2023-07-07. The listed applicant is American Orthodontics. The 510(k) number is K232011.

When did Cleo receive FDA 510(k) clearance?

Cleo received FDA 510(k) clearance on 2023-07-07, under 510(k) number K232011.

Who is the listed applicant for Cleo?

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

What is the FDA product code for Cleo?

The FDA product code for Cleo is NJM.

Other records listing American Orthodontics as applicant

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Related Devices (Code: NJM)

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.

K232827LightForce Orthodontic SystemLightforce OrthodonticsK231635A-Line AdvancedBiocetec Co., Ltd.K230225DynaFlex Clear Brackets & ButtonsDyna FlexK222847Ceramic Brackets OrthometricOrthometric - Industria E Comercio DE Produtos MedicosK222764LightForce Orthodontic SystemLightforce OrthodonticsK220689Vatech ClismileRayence Co., Ltd.

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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