Single Use CO2 Laser Fiber (HAF005001)

The Single Use CO2 Laser Fiber (HAF005001) is a single-use hollow optical fiber designed to deliver CO2 laser energy at 10.6 μm wavelength for ablation, coagulation, excision, incision, and vaporization of soft tissue during open, endoscopic, and laparoscopic surgical procedures. The device is contraindicated for use on the heart, central circulatory system, or central nervous system.

The subject device matches the predicate (ProFlex CO2 Laser Fiber, K203799) in laser wavelength (10.6 μm), maximum power (40 W), power transmission (60–70%), lumen diameter (500 μm), outer diameter (1040 μm), fiber length (2 m), connector type (SMA905), single use, and EtO sterilization method. The subject device has a 5-year shelf life versus the predicate's 3 years, and lacks the predicate's additional fluoropolymer cladding layer, though this layer is stated to serve only mechanical enhancement and not affect safety or performance.

ISO 10993-1:2018 (biological evaluation including cytotoxicity, sensitization, irritation, acute systemic toxicity, and pyrogenicity); ISO 11607-1:2019 and ISO 11607-2:2019 (packaging validation); ISO 11135:2014 (EtO sterilization validation); and performance testing for laser transmission and minimum bending radius.

The subject device has identical indications for use (with the narrow exclusion of cardiac and central nervous system tissue), equivalent technological characteristics and materials, and comparable performance specifications to the legally marketed predicate. Non-clinical bench testing including biocompatibility, sterilization validation, packaging integrity after accelerated aging, and laser transmission performance all yielded positive results, supporting that the device functions safely and effectively as intended. The minor design differences (absence of fluoropolymer cladding, extended shelf life) do not materially alter safety or performance relative to the predicate.