510(k) K253504— Volnewmer

Substantially Equivalent

Classys, Inc.

Clearance details

Applicant: Classys, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2025-10-31
Decision date: 2026-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

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.