510(k) K251632— Optimas MAX System

Substantially Equivalent

InMode , Ltd.

Clearance details

Applicant: InMode , Ltd.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2025-05-28
Decision date: 2025-06-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Yokneam Lillit, FR

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.