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FDA 510(k)

BeaMed Laser Surgery Fibers

K-Number: K232769 · 2023-12-06

ApplicantBt Beamedical Tachnoogies Ltd. (Beamed)
Decision Date2023-12-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BeaMed Laser Surgery Fibers is a medical device manufactured by Bt Beamedical Tachnoogies Ltd. (Beamed). It received FDA 510(k) clearance on 2023-12-06 under approval number K232769. 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 BeaMed Laser Surgery Fibers?

BeaMed Laser Surgery Fibers is a medical device that received FDA 510(k) clearance on 2023-12-06. It is manufactured by Bt Beamedical Tachnoogies Ltd. (Beamed). The 510(k) number is K232769.

When was BeaMed Laser Surgery Fibers approved by the FDA?

BeaMed Laser Surgery Fibers received FDA 510(k) clearance on 2023-12-06, under approval number K232769.

What company makes BeaMed Laser Surgery Fibers?

BeaMed Laser Surgery Fibers is manufactured by Bt Beamedical Tachnoogies Ltd. (Beamed).

What is the FDA product code for BeaMed Laser Surgery Fibers?

The FDA product code for BeaMed Laser Surgery Fibers is GEX. This falls under the Gastroenterology category.

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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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