Sharplan Surgical Diode Laser

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

Full name

Sharplan Lasers, Inc. Surgical Diode Laser

510(k) Number

K953794 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Sharplan Model 1050 Sealed-Off CO2 Surgical Laser

  Class II

  FDA 510(k) K890287 Active Cleared 12 Apr 1989

• Sharplan Model 1080S CO2 Surgical Laser

  Class II

  FDA 510(k) K933918 Active Cleared 25 Aug 1994

• Sharplan Model 750 Remote Control Unit (Rcu)

  Class II

  FDA 510(k) K890286 Active Cleared 5 Apr 1989

• Sharplan Nd:yag Lasers for ENT and Neck Surgery

  Class II

  FDA 510(k) K900345 Active Cleared 10 Apr 1990

• Sharplan CO2 Surg. Laser, Mo. 1039 Surgicenter 40

  Class II

  FDA 510(k) K921146 Active Cleared 8 Jun 1992

• Sharplan Nd:yag Surgical Laser, Model 3060 Sharplaser 60

  Class II

  FDA 510(k) K926543 Active Cleared 9 Mar 1994

See all devices from Sharplan Lasers, Inc. →

• What is the Sharplan Surgical Diode Laser used for in clinical settings?

  The Sharplan Surgical Diode Laser is designed for precise tissue ablation and coagulation, enabling controlled cutting, vaporization, or sealing of biological tissues with minimal thermal damage. Its applications span general and plastic surgery, where reducing collateral harm to surrounding tissues is critical. The device’s wavelength and energy delivery system are optimized for these procedures, ensuring better surgical outcomes and improved patient recovery.

• Is the Sharplan Surgical Diode Laser intended for single-use or reusable applications?

  This device is explicitly supplied as a reusable medical instrument. It is engineered for sterile operating environments and requires proper calibration, maintenance, and adherence to manufacturer guidelines to ensure safe and effective reuse. Reusability is supported by its robust design, but strict protocols must be followed to prevent contamination or degradation of performance.

• What regulatory pathway does the Sharplan Surgical Diode Laser follow, and what does that mean for clinicians?

  The device is regulated under the FDA’s 510(k) clearance pathway (K953794) and is classified as substantially equivalent to prior generations of surgical lasers. This means it has undergone rigorous review to demonstrate safety and effectiveness comparable to existing devices in its category (product code GEX). Clinicians can rely on its established performance standards, though they must still follow Sharplan’s operational and maintenance instructions to comply with regulatory requirements.

• Does the Sharplan Surgical Diode Laser have any special considerations for storage or handling?

  While specific storage instructions are not detailed in the regulatory data, reusable surgical lasers like this one require careful handling to maintain sterility and functionality. The device should be stored in a clean, dry environment, protected from physical damage or exposure to contaminants. Manufacturer guidelines likely include protocols for cleaning, disinfection, and calibration intervals to ensure long-term reliability and safety.

• What advisory committee reviewed this device, and how does that relate to its intended use?

  The device was reviewed by the FDA’s Surgical and Urological Devices (SU) Advisory Committee, which specializes in general and plastic surgery-related technologies. This committee evaluates devices for their safety, effectiveness, and compliance with clinical needs in these surgical specialties. The review’s focus on general and plastic surgery aligns with the device’s intended use for precise tissue manipulation in those fields.