LGO-Surgical Laser Fibers

LGO-Surgical Laser Fibers are single-use or reusable (up to 10 uses) laser fiber delivery devices intended to transmit laser radiation to target tissue during surgical procedures. They are used with cleared surgical lasers operating at wavelengths between 500 nm and 2200 nm, equipped with SMA 905 connectors, in general surgery, plastic surgery, and dermatology applications.

The device features a core diameter of 145–1000 µm (slightly smaller than the predicate's 200–1000 µm range), construction materials including silica quartz glass, hard clad, silicone, polyimide, nylon, and ETFE, and operates across 500–2200 nm wavelengths matching the predicate. Both support single-use and reusable (10×) configurations with ethylene oxide sterilization and SMA 905 connectors, though the subject device does not support SMA 906 compatibility.

ISO 10933 series (biocompatibility testing including cytotoxicity, skin sensitization, systemic toxicity, and irritation), ISO 11135:2014 (ethylene oxide sterilization validation), ISO 17665-1:2006 (moist heat sterilization), ISO 11607 series (packaging and sterile barrier validation), plus functional tests including beam profile, light transmission, connector pull/torque tests, and accelerated aging studies.

The LGO-Surgical Laser Fibers are substantially equivalent because they share the same product code (GEX), indications for use (laser radiation delivery with 500–2200 nm wavelengths via SMA 905 connectors), operating wavelength range, sterilization method, and usage modes (single or 10× reusable) as the predicate device. Minor differences in core diameter range and construction materials (absence of acrylate and SMA 906 support) do not raise new safety or effectiveness concerns, as demonstrated by biocompatibility and functional performance testing meeting all acceptance criteria.