neoLaser Laser Surgery Fibers

The neoLaser Laser Surgery Fibers are sterile, single-use fiber optic devices that deliver laser energy to soft tissue in contact and non-contact modes for surgical applications. They transmit energy from a laser system to treatment sites and can be used via endoscopes or cytoscopes across multiple surgical specialties including general surgery, urology, dermatology, vascular surgery, and plastic surgery.

Both the subject and predicate devices share identical technical specifications: silica quartz glass core with optional Hardclad cladding, wavelength range 450–2100 nm, core diameter 200–1000 μm, maximal laser power 100W, shelf life 5 years, SMA 905 connectors, sterilization by ethylene oxide, and single-use sterile double-pouched packaging. Fiber tip types include flat, conical, ball, spherical, or bent bare fibers with outer diameters from 1.0–1.8 mm.

Not stated in this summary. The submission references packaging seal strength, dye penetration, microbial barrier testing, shelf-life validation, sterilization process validation, endotoxin testing (LAL), bioburden testing, biocompatibility testing, and thermal safety validation, but no specific consensus standards (ISO, IEC, ASTM) are cited.

The neoLaser fibers are substantially equivalent because they are identical in design, materials, performance characteristics, indications for use, and technical specifications to the predicate BeaMed fibers (K232769). Both devices transmit laser energy across the same wavelength range using identical fiber construction, operate in the same contact and non-contact modes, support the same maximum power and wavelength specifications, and are indicated for the same surgical applications. Performance testing demonstrates equivalent safety and effectiveness profiles, eliminating any meaningful differences in intended use or technological function.