FDA 510(k)

Lithoblast Single Use Holmium Laser Fibers

Número K: K250776 · 2025-10-14

Data da decisão2025-10-14

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Lithoblast Single Use Holmium Laser Fibers is the device name listed in this FDA 510(k) record. The listed applicant is Dawell Medical, LLC. It received FDA 510(k) clearance on 2025-10-14 under 510(k) number K250776. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Lithoblast Single Use Holmium Laser Fibers?

Lithoblast Single Use Holmium Laser Fibers is a medical device that received FDA 510(k) clearance on 2025-10-14. The listed applicant is Dawell Medical, LLC. The 510(k) number is K250776.

When did Lithoblast Single Use Holmium Laser Fibers receive FDA 510(k) clearance?

Lithoblast Single Use Holmium Laser Fibers received FDA 510(k) clearance on 2025-10-14, under 510(k) number K250776.

Who is the listed applicant for Lithoblast Single Use Holmium Laser Fibers?

The FDA 510(k) record lists Dawell Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lithoblast Single Use Holmium Laser Fibers?

The FDA product code for Lithoblast Single Use Holmium Laser Fibers is GEX. This falls under the Gastroenterology category.

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