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Diomed 25 25W Surgical Diode Laser

by Dio-Med Corp. 3 variants

510(k) K933525

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 NumberK933525 Date1 Mar 1994ClearedStatusActive

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  • Withdrawn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 Diomed 25 25W Surgical Diode Laser is a surgical laser designed for cutting and coagulation in soft tissue procedures. As a diode laser, it emits coherent light at a specific wavelength to achieve precise tissue effects, commonly used in general and plastic surgery applications.

This device is supplied as a reusable medical instrument and has been granted FDA 510(k) clearance under the product code GEX. It is intended for use in controlled surgical environments and requires proper handling, maintenance, and adherence to regulatory guidelines to ensure safety and efficacy. The device’s specifications include a power output of 25 watts, as indicated by its model designation.

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See all devices from Diomed, Inc. →

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.

  • What types of surgical procedures is the Diomed 25 25W Surgical Diode Laser primarily used for?

    The Diomed 25 25W Surgical Diode Laser is designed for cutting and coagulation in soft tissue procedures, commonly applied in general and plastic surgery. Its 25-watt power output allows for precise tissue effects, making it suitable for controlled surgical environments where detailed manipulation of soft tissue is required.

  • Is the Diomed 25 25W Surgical Diode Laser intended for single-use or reusable applications?

    The Diomed 25 25W Surgical Diode Laser is explicitly supplied as a reusable medical instrument. Like all reusable devices, it requires proper cleaning, maintenance, and adherence to regulatory guidelines to ensure safety and functionality between uses.

  • How was the FDA clearance for this device determined, and what does that mean for its use?

    The Diomed 25 25W Surgical Diode Laser received FDA 510(k) clearance under the product code GEX, with a decision labeled as *Substantially Equivalent* (SESE). This means the FDA determined it is as safe and effective as a legally marketed device already on the market, allowing it to be used in controlled surgical settings for cutting and coagulation in soft tissue procedures, provided it is handled and maintained according to regulatory standards.

  • What power output does the Diomed 25 25W Surgical Diode Laser provide, and how does that influence its use?

    The Diomed 25 25W Surgical Diode Laser delivers a 25-watt power output, as indicated by its model designation. This consistent power level enables precise cutting and coagulation in soft tissue procedures, making it suitable for applications in general and plastic surgery where controlled energy delivery is critical.