Fraxis— 510(k) K172096

Substantially Equivalent

Ilooda Co,., Ltd.

FDA 510(k) clearance K172096 for Fraxis, Substantially Equivalent on 2017-08-09. Applicant: Ilooda Co,., Ltd..

Clearance details

Applicant: Ilooda Co,., Ltd.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2017-07-11
Decision date: 2017-08-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Suwon-Si Gyeonggido, KR

Download summary PDF View on FDA.gov ↗

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.