LASER THERMAL THERAPY KIT

The Laser Thermal Therapy Kit is a sterile, single-use device composed of a fiber optic (272 μm core quartz fiber, 2 m length) and a 21-gauge introducer needle. It transfers 1064 nm laser energy from a laser unit to tissue sites for vaporization, ablation, necrosis, or coagulation of soft tissue through interstitial irradiation across multiple surgical specialties including cardiovascular thoracic surgery, dermatology, gastroenterology, general surgery, gynecology, orthopedics, and urology.

The subject device is identical to the primary predicate (K230460) in all technological characteristics: 1064 nm wavelength, continuous wave operation, 7W maximum power, elliptical lesion shape, SMA 905 proximal connector, bare fiber tip, stainless steel introducer needle, and ETO sterilization. Minor packaging dimension changes for the fiber optic (250×380 mm vs. 300×570 mm) and external stopper diameter reduction (7.2 mm vs. 9.9 mm) are noted as equivalent with no impact on technical performance.

Not stated in this summary.

The Laser Thermal Therapy Kit is substantially equivalent to predicate K230460 (same device name and manufacturer) because it shares identical technological characteristics, materials, chemical composition, principle of operation, and energy source. The 510(k) summary explicitly states no additional performance testing was needed since subject and predicate devices are identical in technological characteristics, with biocompatibility, sterility, and shelf-life testing being exactly the same as previously cleared. Minor packaging and dimensional variations pose no new risks or safety alterations.