Acutome 2000 Color-Corrected Laparoscopic C02 Laser Coupler and Sleeves

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

510(k) Number

K942868 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Unimax Model 2000 Color-Corrected Microspot CO2

  Class II

  FDA 510(k) K920821 Active Cleared 21 May 1992

• Acutome(R) 150 Multi-Wavelength Color-Corrected(Tm) Laser Handpiece

  Class II

  FDA 510(k) K950215 Active Cleared 15 Jun 1995

• What is the Acutome 2000 Color-Corrected Laparoscopic CO₂ Laser Coupler and Sleeves used for?

  The Acutome 2000 is designed for laparoscopic surgical procedures, enabling precise tissue incision, coagulation, and vaporisation using CO₂ laser technology. Its color-corrected feature enhances visual feedback during surgery, improving accuracy and reducing thermal damage to surrounding tissues. This makes it suitable for general, plastic, and other surgical specialties requiring minimally invasive techniques.

• How is the Acutome 2000 system supplied, and what are its components?

  The system consists of a reusable CO₂ laser coupler paired with single-use sleeves. The reusable coupler connects to CO₂ laser systems, while the sleeves are disposable and designed for sterile use in operating rooms. The system includes multiple sleeve sizes to accommodate different laparoscopic instruments, ensuring adaptability for various surgical needs.

• Is the Acutome 2000 coupler reusable, and how should it be maintained?

  Yes, the coupler is reusable. To maintain performance and sterility, it must be stored and handled according to the manufacturer’s guidelines for laser optics and reusable components. Proper cleaning and storage are critical to preserving its functionality and ensuring safe, repeated use in surgical settings.

• Are there any restrictions on using the Acutome 2000 system with MRI equipment?

  The manufacturer does not specify any MRI safety restrictions for the Acutome 2000 system. However, as with all laser systems, clinicians should verify compatibility with their specific MRI environment and follow institutional protocols to avoid interference or safety hazards during combined procedures.

• What regulatory clearance does the Acutome 2000 hold, and under what advisory committee was it reviewed?

  The Acutome 2000 received FDA 510(k) clearance (K942868) under the General, Plastic Surgery advisory committee category. This clearance indicates the device was determined to be substantially equivalent to a legally marketed predicate, ensuring it meets regulatory standards for safety and effectiveness in its intended use.