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FDA 510(k)

Thulium Fiber Laser (FiberLAZE+, FiberLAZE)

K-Number: K242987 · 2024-12-17

ApplicantAllengers Global Healthcare Private Limited
Decision Date2024-12-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Thulium Fiber Laser (FiberLAZE+, FiberLAZE) is a medical device manufactured by Allengers Global Healthcare Private Limited. It received FDA 510(k) clearance on 2024-12-17 under approval 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.

Frequently Asked Questions

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. It is manufactured by Allengers Global Healthcare Private Limited. The 510(k) number is K242987.

When was Thulium Fiber Laser (FiberLAZE+, FiberLAZE) approved by the FDA?

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

What company makes Thulium Fiber Laser (FiberLAZE+, FiberLAZE)?

Thulium Fiber Laser (FiberLAZE+, FiberLAZE) is manufactured by Allengers Global Healthcare Private Limited.

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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Other Devices by Allengers Global Healthcare Private Limited

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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