Lithoblast Single Use Holmium Laser Fibers— 510(k) K250776

Name: FDA 510(k) clearance K250776
Creator: U.S. Food and Drug Administration
Published: 2025-10-14

Substantially Equivalent

Dawell Medical, LLC

FDA 510(k) clearance K250776 for Lithoblast Single Use Holmium Laser Fibers, Substantially Equivalent on 2025-10-14. Applicant: Dawell Medical, LLC. Device class: 2.

Clearance details

Applicant: Dawell Medical, LLC
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2025-03-14
Decision date: 2025-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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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.