DeviceClearance

MyEllevate— 510(k) K230510

Substantially Equivalent

Cynosure, LLC

FDA 510(k) clearance K230510 for MyEllevate, Substantially Equivalent on 2023-07-06. Applicant: Cynosure, LLC.

Clearance details

Applicant
Cynosure, LLC
Product code
Code GAT
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wesford, MA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code GAT

product code GAT
Death
19
Injury
4,163
Malfunction
8,646
Other
2
Total
12,830

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.