FDA 510(k)

Thulium Fiber Laser (FiberLAZE+, FiberLAZE)

Número K: K242987 · 2024-12-17

RequerenteAllengers Global Healthcare Private Limited

Data da decisão2024-12-17

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Thulium Fiber Laser (FiberLAZE+, FiberLAZE) is the device name listed in this FDA 510(k) record. The listed applicant is Allengers Global Healthcare Private Limited. It received FDA 510(k) clearance on 2024-12-17 under 510(k) number K242987. 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 Thulium Fiber Laser (FiberLAZE+, FiberLAZE)?

Thulium Fiber Laser (FiberLAZE+, FiberLAZE) is a medical device that received FDA 510(k) clearance on 2024-12-17. The listed applicant is Allengers Global Healthcare Private Limited. The 510(k) number is K242987.

When did Thulium Fiber Laser (FiberLAZE+, FiberLAZE) receive FDA 510(k) clearance?

Thulium Fiber Laser (FiberLAZE+, FiberLAZE) received FDA 510(k) clearance on 2024-12-17, under 510(k) number K242987.

Who is the listed applicant for Thulium Fiber Laser (FiberLAZE+, FiberLAZE)?

The FDA 510(k) record lists Allengers Global Healthcare Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Thulium Fiber Laser (FiberLAZE+, FiberLAZE)?

The FDA product code for Thulium Fiber Laser (FiberLAZE+, FiberLAZE) is GEX. This falls under the Gastroenterology category.

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Fonte oficial

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