Diomed 15 Diode Laser

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K012398 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• A100 Aesthetic Diode Laser

  Class II

  FDA 510(k) K000982 Active Cleared 1 May 2000

• Diomed 25 25W Surgical Diode Laser

  Class II

  FDA 510(k) K931776 Active Cleared 19 Oct 1993

• Diomed Delta 25

  Class II

  FDA 510(k) K063828 Active Cleared 25 Jan 2007

• Diomed 25 Surgical Diode Laser, Gynecology Applic

  Class II

  FDA 510(k) K914519 Active Cleared 16 Sep 1993

• Diomed 25 Surgical Diode Laser, Urology Applicat

  Class II

  FDA 510(k) K914520 Active Cleared 22 Jan 1993

• Diomed 25 Surgical Diode Laser, Gen Surg Applicat

  Class II

  FDA 510(k) K914521 Active Cleared 15 Jan 1993

See all devices from Diomed, Inc. →

• How is the Diomed 15 Diode Laser maintained, and why is this important for its use?

  The Diomed 15 Diode Laser is designed as a reusable medical instrument, meaning it requires regular maintenance to ensure safety and performance. Proper cleaning and calibration are essential to prevent contamination, damage to components, and to maintain the precision of its continuous-wave radiation delivery. Since it operates in controlled clinical settings for procedures like tissue ablation, coagulation, and vaporisation, adherence to maintenance protocols is critical to avoid malfunctions that could compromise patient outcomes.

• What types of surgical procedures is this laser intended for, and how does its design support those uses?

  The Diomed 15 Diode Laser is specifically designed for general and plastic surgery procedures, where precise tissue manipulation—such as ablation, coagulation, or vaporisation—is required. Its flexible optical fiber allows for targeted delivery of radiation, enabling surgeons to access and treat areas with greater precision compared to traditional surgical tools. This design is particularly useful in procedures where minimal tissue damage and controlled energy application are critical.

• Is the Diomed 15 Diode Laser compatible with MRI environments, and what should clinicians consider if they plan to use it near MRI machines?

  The provided data does not include any specific information regarding the Diomed 15 Diode Laser’s compatibility with MRI environments. Clinicians should exercise caution and consult the manufacturer’s guidelines or additional safety documentation to assess potential risks, such as electromagnetic interference or safety hazards, before using this device in or near an MRI setting. Always verify compatibility with your facility’s MRI protocols to ensure patient and staff safety.

• What distinguishes the Diomed 15 Diode Laser from other surgical lasers, and how was its regulatory pathway determined?

  The Diomed 15 Diode Laser is classified under the FDA’s product code GEX for general surgical lasers and was granted 510(k) clearance through a traditional review pathway, determined to be *substantially equivalent* to a predicate device. This classification and clearance process reflects its intended use for precise tissue procedures in general and plastic surgery, where continuous-wave radiation via a flexible fiber is advantageous. The regulatory pathway confirms its compliance with safety and performance standards for surgical lasers.