LMT-3000— 510(k) K172818

Substantially Equivalent

Lameditech Co. , Ltd.

FDA 510(k) clearance K172818 for LMT-3000, Substantially Equivalent on 2018-03-07. Applicant: Lameditech Co. , Ltd..

Clearance details

Applicant: Lameditech Co. , Ltd.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2017-09-18
Decision date: 2018-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 234, Beotkkot-Ro, Geumcheon-Gu, 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.