Lithoblast Single Use Holmium Laser Fibers

The LithoBlast Single-Use Holmium Laser Fibers are single-use surgical fiber-optic laser delivery devices that transmit Ho:YAG laser energy (2000-2200 nm) in a forward direction. They are indicated for use in surgical specialties where a compatible Ho:YAG laser system with an SMA 905 connector has received regulatory clearance, with four core diameter options: 272, 365, 550, and 940 micrometers.

The subject device features SMA 905 connectors, core fiber sizes from 272 to 940 µm (a subset of predicate sizes 150-1000 µm), flat distal tip configuration, standard silica core fiber with fluoropolymer coating, and operating power ranges of 0-20W to 0-80W depending on core size. These characteristics are technologically comparable to the predicate device, with the subject operating within a narrower range of the predicate's specifications.

Not stated in this summary.

The LithoBlast device is substantially equivalent to the predicate (Laser Peripherals Family of Laser Fibers, K170366) because both share the same product code (GEX), regulation (21 CFR 878.4810), intended use, and fiber construction. The subject device's specifications represent a technologically comparable subset of the predicate's designs. Bench performance testing including power transmission, connection temperature, dimensional specifications, tensile strength, and compatibility demonstrated that the LithoBlast fiber is as safe, effective, and performs as well as or better than the predicate device.