FDA 510(k)

钬光纤激光器（FiberLAZE+，FiberLAZE）

K号: K242987 · 2024-12-17

申请人Allengers Global Healthcare Private Limited

决定日期2024-12-17

产品代码GEX

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决定实质等同

器械摘要

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.

常见问题

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.

列明Allengers Global Healthcare Private Limited为申报人的其他记录

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K231718Holmium 医疗激光

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