Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)

The Halo Sterile Single-use Radial Fiber is a laser surgical instrument fiber designed for use with compatible diode laser systems operating at wavelengths between 500nm and 2200nm. It is intended for general surgical operations such as incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissues in contact or non-contact mode, with particular application to endovascular coagulation of blood vessels.

The device uses silica glass fiber core material with core diameters of 0.40mm or 0.60mm, outer diameters ranging from 0.9mm to 1.3mm, and maximum output power of 1-30 watts. It features an SMA 905 connector, is single-use only, and is sterilized by ethylene oxide gas. The fiber is radial-typed with a conical distal end to radiate laser energy radially.

ISO 11135 (EO sterilization), ISO 11737 (microbiological methods), ISO 11138 (biological indicators), ISO 10993 series (biocompatibility including cytotoxicity, sensitization, pyrogenicity, hemolysis, genotoxicity), ASTM F88, F1929, F2096, F1886 (packaging integrity), and ANSI/AAMI ST72 (bacterial endotoxins).

The Halo device uses the same or similar technology as the predicate WONTECH Surgical Optic Fibers (K241643), with identical product code (GEX), regulatory class (II), indications for use, target population, wavelength range, fiber core materials, connectors, sterilization method, and biocompatibility standards. Minor differences exist only in outer diameter specifications, which do not impact safety or effectiveness. Performance testing confirms the device meets all acceptance criteria.