Fiberlase CO2 Laser Waveguide

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

Full name

Surgilase Fiberlase CO2 Laser Waveguide

510(k) Number

K924664 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Surgilase CO2 Surgical Laser System Model SL80

  Class II

  FDA 510(k) K884092 Active Cleared 13 Oct 1988

• Model SL60 Surgilase CO2 Surgical Laser Systems

  Class II

  FDA 510(k) K884311 Active Cleared 27 Oct 1988

• Surgilase Yag 100 Surgical Laser System

  Class II

  FDA 510(k) K902211 Active Cleared 29 Jun 1990

• Surgilase 40S

  Class II

  FDA 510(k) K852470 Active Cleared 13 Nov 1985

• Model SL45 Surgilase CO2 Surgical Laser Systems

  Class II

  FDA 510(k) K884313 Active Cleared 27 Oct 1988

• Nd:yag 100 Surgical Laser for Neuro & Pulmonary

  Class III

  FDA 510(k) K875042 Active Cleared 24 Jun 1988

See all devices from Surgilase, Inc. →

• What is the Surgilase Fiberlase CO₂ Laser Waveguide used for?

  The Fiberlase CO₂ Laser Waveguide is designed for surgical procedures in plastic surgery where controlled tissue ablation, coagulation, or vaporisation is required. Its flexible design allows precise laser energy delivery to challenging anatomical areas, making it ideal for procedures where traditional laser tools may be less accessible or effective.

• How is the Surgilase Fiberlase CO₂ Laser Waveguide supplied and what does this mean for sterility?

  This waveguide is supplied as a single-use device, ensuring it remains sterile and free from cross-contamination risks. Single-use design eliminates the need for reprocessing, which reduces the potential for infection and maintains consistent performance for each procedure.

• Does the waveguide require any special handling or storage instructions?

  The waveguide must be handled according to the manufacturer’s guidelines to preserve its performance and safety. Since it is intended for sterile surgical environments, it should be stored in a clean, dry place away from direct sunlight or extreme temperatures. The renewable tip feature allows for easy replacement, but the entire waveguide is designed for single-use only.

• What distinguishes the Fiberlase waveguide from other CO₂ laser tools?

  The Fiberlase waveguide is distinguished by its flexibility, allowing it to be integrated with handpieces, endoscopes, or robotic-assisted systems for access to complex anatomical areas. It also includes an aiming beam to enhance surgical precision and a renewable tip, which extends usability while maintaining sterility for each procedure.

• Is the waveguide compatible with robotic-assisted surgical systems?

  Yes, the Fiberlase CO₂ Laser Waveguide is designed to be compatible with robotic-assisted systems, enabling precise laser energy delivery in minimally invasive procedures. Its flexible nature makes it adaptable to various surgical platforms, including those used in robotic surgery.