The Evolve System with the Transform Applicator— 510(k) K231495

Substantially Equivalent

InMode , Ltd.

FDA 510(k) clearance K231495 for The Evolve System with the Transform Applicator, Substantially Equivalent on 2023-10-13. Applicant: InMode , Ltd..

Clearance details

Applicant: InMode , Ltd.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2023-05-23
Decision date: 2023-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam Illit, IL

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.