Data / Medical devices / United States / Dawell Medical, LLC
Dawell Medical, LLC: FDA-registered device maker in Cutler Bay, FL, United States, 1 510(k) clearance
Dawell Medical, LLC is registered with the FDA (registration 3033126947) in Cutler Bay, FL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 14, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033126947
- Address
- 18505 Sw 104th Ave Unit 26, Cutler Bay, FL, United States, 33157
- Owner or operator
- Dawell Medical, LLC (10095313)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- February 24, 2026
- Registered through
- 2026
- Brand names listed
- LithoBlast Single-Use Holmium Laser Fibers
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 14, 2025 | K250776 | Lithoblast Single Use Holmium Laser Fibers | GEX | Substantially Equivalent | Dawell Medical, LLC | accessdata.fda.gov |
Compare with other makers
Updated October 14, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.