Lithoblast Single Use Holmium Laser Fibers
Dawell Medical, LLC
DAWELL MEDICAL, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3033126947 | 3033126947 | DAWELL MEDICAL, LLC | 1 | Y | 2026-01-01 | 18505 Sw 104th Ave Unit 26 Cutler Bay FL US 33157 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 348576 | 1181826687 | K250776 | Lithoblast Single Use Holmium Laser Fibers | GEX | 2025-10-14 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GEX | 1 | 2025-10-14 |
PMN#
GUDID#
Lithoblast Single-Use Holmium Laser Fibers - 272 µm Laser Fiber Blast Shield C
2026-03-10
Lithoblast Single-Use Holmium Laser Fibers - 272 µm Laser Fiber Blast Shield C
2026-03-10
Lithoblast Single-Use Holmium Laser Fibers - 272 µm Laser Fiber Blast Shield A
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 272 µm Laser Fiber Blast Shield B
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 272 µm Laser Fiber Air Gap A
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 272 µm Laser Fiber Air Gap B
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 272 µm Laser Fiber Air Gap C
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 365 µm Laser Fiber Regular A
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 365 µm Laser Fiber Regular B
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 365 µm Laser Fiber Regular C
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 365 µm Laser Fiber Blast Shield A
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 365 µm Laser Fiber Blast Shield B
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 365 µm Laser Fiber Blast Shield C
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 365 µm Laser Fiber Air Gap A
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 365 µm Laser Fiber Air Gap B
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 365 µm Laser Fiber Air Gap C
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 550 µm Laser Fiber Regular A
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 550 µm Laser Fiber Regular B
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 550 µm Laser Fiber Regular C
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 550 µm Laser Fiber Blast Shield A
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 550 µm Laser Fiber Blast Shield B
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 550 µm Laser Fiber Blast Shield C
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 550 µm Laser Fiber Air Gap A
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 550 µm Laser Fiber Air Gap B
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 550 µm Laser Fiber Air Gap C
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 940 µm Laser Fiber Regular A
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 940 µm Laser Fiber Regular B
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 940 µm Laser Fiber Regular C
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 940 µm Laser Fiber Air Gap A
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 940 µm Laser Fiber Air Gap B
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 940 µm Laser Fiber Air Gap C
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 272 µm Laser Fiber Regular A
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 272 µm Laser Fiber Regular B
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 272 µm Laser Fiber Regular C
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 272 µm Laser Fiber Blast Shield A
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 272 µm Laser Fiber Blast Shield B
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 272 µm Laser Fiber Air Gap A
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 272 µm Laser Fiber Air Gap B
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 272 µm Laser Fiber Air Gap C
2026-03-02
Lithoblast Single-Use Holmium Laser Fibers - 365 µm Laser Fiber Regular A
2026-03-02