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BeaMed Laser Surgery Fibers

by Bt Beamedical Tachnoogies Ltd. (Beamed)

510(k) K232769

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK232769 Date6 Dec 2023ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The BeaMed Laser Surgery Fibers are Powered Laser Surgical Instruments (GEX classification) designed for precise soft tissue manipulation. They deliver laser energy for incision, excision, vaporization, ablation, hemostasis, or coagulation in surgical procedures, including open and endoscopic applications.

These fibers are supplied as single-use, non-sterile devices intended for surgical settings. They require sterilization prior to use and are classified under FDA 510(k) clearance (K232769) as Class II – Special Controls. Compliance with regulatory standards ensures safe integration into general and plastic surgery workflows.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Are these fibers intended for reusable use in surgery, or are they designed for single-use after sterilization?

    These fibers are explicitly labeled as single-use, non-sterile devices and require sterilization before their first use. They are not designed for reuse after sterilization, as the manufacturer specifies they must be sterilized prior to use in surgical settings.

  • What types of surgical procedures can these fibers be used for, and what specific laser applications do they support?

    The BeaMed Laser Surgery Fibers are designed for precise soft tissue manipulation in both open and endoscopic surgeries. They deliver laser energy for tasks like incision, excision, vaporization, ablation, hemostasis, or coagulation, making them suitable for general and plastic surgery workflows.

  • How are these fibers supplied, and what steps must be taken before they can be used in a procedure?

    The fibers are supplied non-sterile and must undergo sterilization prior to use. Since they are single-use, they cannot be reused after sterilization, and clinicians must ensure proper sterilization protocols are followed before integrating them into surgical procedures.

  • What regulatory pathway was followed for FDA clearance, and what classification does this device hold?

    The BeaMed Laser Surgery Fibers were cleared through the FDA 510(k) process (K232769) under the Traditional Review pathway. They are classified as Class II – Special Controls and are categorized under the Powered Laser Surgical Instruments (GEX) product code, ensuring compliance with regulatory standards for general and plastic surgery applications.