LM-9300 Plus Lithotripter— 510(k) K213772

Name: FDA 510(k) clearance K213772
Creator: U.S. Food and Drug Administration
Published: 2023-01-19

Substantially Equivalent

Lite-Med, Inc.

FDA 510(k) clearance K213772 for LM-9300 Plus Lithotripter, Substantially Equivalent on 2023-01-19. Applicant: Lite-Med, Inc.. Device class: 2.

Clearance details

Applicant: Lite-Med, Inc.
Product code: Code LNS
Device class: Class 2
Regulation: 21 CFR 876.5990
Advisory panel: Gastroenterology, Urology
Date received: 2021-12-02
Decision date: 2023-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code LNS

view all

K261086 — Break Wave2026-04-29
K252913 — Break Wave2026-01-12
K242922 — Extracorporeal Shock Wave Lithotripter (U200)2025-06-18
K221903 — Delta III Pro2023-02-22
K201001 — Modulith SLX-F22021-03-30

More clearances from Lite-Med, Inc.

view all

K142561 — LM-9300 ELMA Lithotripter2015-03-20
K103217 — LITE-MED LM-9200 ELMA2011-09-28

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.