MyEllevate
K-Number: K230510 · 2023-07-06
ApplicantCynosure, LLC
Decision Date2023-07-06
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
MyEllevate is a medical device manufactured by Cynosure, LLC. It received FDA 510(k) clearance on 2023-07-06 under approval 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. It is manufactured by Cynosure, LLC. The 510(k) number is K230510.
When was MyEllevate approved by the FDA?
MyEllevate received FDA 510(k) clearance on 2023-07-06, under approval number K230510.
What company makes MyEllevate?
MyEllevate is manufactured by Cynosure, LLC.
What is the FDA product code for MyEllevate?
The FDA product code for MyEllevate is 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.