WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)

WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) are single-use, sterile surgical laser delivery fibers indicated for use in all surgical specialties with compatible laser systems operating at wavelengths between 532nm–2200nm and SMA 905 connectors. They deliver laser energy for incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissue in contact or non-contact modes, with specific application to endovascular blood vessel coagulation.

The device offers 400 and 600 micron fiber core sizes with outer diameters of 730 and 750 microns respectively, made of silica glass. It supports maximum power output of 1–30 watts and operates across the specified wavelength range. Two variants are offered: bare-type fibers (BA400/BA600) with flat distal ends for straight laser radiation, and radial-type fibers (BA400R/BA600R) with conical distal ends for radial laser emission. The device is EO gas sterilized and single-use.

ISO 11135:2014 (EO sterilization validation); ISO 11138-1 and -2:2017 (biological indicators); ISO 11737-1 and -2 (microbiological methods); ISO 11607 (packaging for sterilized devices); ISO 10993-7:2008 (ethylene oxide residuals biocompatibility); ASTM F1929-15 (dye penetration seal leak detection); ASTM F88/F88M-15 (seal strength testing); IEC 61754-22 (SMA905 connector specification).

The proposed device uses identical or substantially similar technology to the predicate K220189 (LISA Laser Surgical Fibers). Both are single-use, EO gas-sterilized surgical laser fibers with silica cores intended for general surgical applications. The proposed device's wavelength range (532–2100nm) and power output (1–30W) are subsets of the predicate's range (500–2100nm, 1–300W), and its SMA 905 connector specification is included within the predicate's broader connector support. Fiber sizes, materials, sterilization method, and biocompatibility profiles are equivalent. Performance testing confirms the device can be used safely and effectively for its stated indications without raising new safety or effectiveness concerns.