Lithoblast Single Use Holmium Laser Fibers— 510(k) K250776
Substantially EquivalentDawell Medical, LLC
FDA 510(k) clearance K250776 for Lithoblast Single Use Holmium Laser Fibers, Substantially Equivalent on 2025-10-14. Applicant: Dawell Medical, LLC.
Clearance details
- Applicant
- Dawell Medical, LLC
- Product code
- Code GEX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
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, through . 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.