SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA; TCRH 7-SMA; FEF 2.2-SMA; CFE 0.6-SMA; SSRH 8Z-SMA; SSRH 4-SMA; SSRH 6-SMA; SSRH 9-SMA; SSRH 10-SMA; SSRH 11-SMA; SSRH 7L-SMA; TCRH 7Z-SMA; FEF 1.8-SMA; CFE 0.55-SMA; CFE 0.36-SMA; LAL 550-SMA; LAL 550Z-SMA; LAL 365-SMA; LAL 365Z-SMA; ER2; ERP2; GR2; GRP2; ER4; ERP4; GR4; GRP4; ER6; ERP6; GR6; GRP6; ER8; ERP8; GR8; GRP8; ER10; ERP10; GR10; GRP10; ER12; ERP12; GR12; GRP12; MD2.5; MD3.5; HP1.0; MTP1.5; MTP3.5; MTRG1.5;

The SLT Select Fiber Delivery System and Contact Tips are optical fiber delivery systems that transmit laser energy (532–1064 nm wavelength) from a laser generator to surgical sites, enabling precise tissue effects including incision, excision, vaporization, and coagulation. The devices are intended for use across multiple surgical specialties including general surgery, urology, gynecology, ENT, neurosurgery, and orthopedics.

The proposed device and predicate device are identical in product code, regulation number, indications for use, transmission efficiency, tensile strength of the fiber-to-connector joint, optical fiber tensile strength, minimum bending working radius, optical fiber bending fatigue resistance, and divergence angle. The devices feature a universal SMA-905 connector compatible with lasers operating in continuous wave or quasi-continuous wave mode with numerical aperture ≤0.35.

Biocompatibility testing was conducted per ISO 10993-5:2009 (in vitro cytotoxicity), ISO 10993-10:2021 (skin sensitization), ISO 10993-23:2021 (intracutaneous reactivity), ISO 10993-11:2017 (pyrogen and acute systemic toxicity). Bench testing and performance validation were performed in accordance with applicable standards.

The proposed device is substantially equivalent to the predicate because it shares identical product code, regulatory classification, indications for use, and patient population. Technological comparison demonstrates matching performance across all critical parameters including transmission efficiency, tensile strength, bending radius, fatigue resistance, and divergence angle. Biocompatibility testing confirms compliance with established safety standards, and bench testing confirms performance parity with the predicate device.