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FDA 510(k)

MyEllevate

K-Number: K230510 · 2023-07-06

ApplicantCynosure, LLC
Decision Date2023-07-06
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MyEllevate is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure, LLC. It received FDA 510(k) clearance on 2023-07-06 under 510(k) number K230510. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MyEllevate?

MyEllevate is a medical device that received FDA 510(k) clearance on 2023-07-06. The listed applicant is Cynosure, LLC. The 510(k) number is K230510.

When did MyEllevate receive FDA 510(k) clearance?

MyEllevate received FDA 510(k) clearance on 2023-07-06, under 510(k) number K230510.

Who is the listed applicant for MyEllevate?

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

What is the FDA product code for MyEllevate?

The FDA product code for MyEllevate is GAT.

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Related Devices (Code: GAT)

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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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