LM-9300 ELMA Lithotripter— 510(k) K142561

Substantially Equivalent

Lite-Med, Inc.

FDA 510(k) clearance K142561 for LM-9300 ELMA Lithotripter, Substantially Equivalent on 2015-03-20. Applicant: Lite-Med, Inc..

Clearance details

Applicant: Lite-Med, Inc.
Product code: Code LNS
Advisory panel: Gastroenterology, Urology
Date received: 2014-09-11
Decision date: 2015-03-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code LNS

product code LNS

Death: 4
Injury: 320
Total: 324

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.