Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM)

The Diode Laser System (LaserPro D 980/810 and Aurolance 980/810/AM) is a surgical laser instrument for soft tissue ablation, vaporization, excision, incision, hemostasis, and coagulation across multiple medical specialties including dermatology, plastic surgery, general surgery, urology, gynecology, and others. The 980 nm models additionally support laser-assisted lipolysis. Each system consists of a main unit, footswitch, power cord assembly, unit key, and protective eyewear.

The proposed devices use diode laser technology with 810 nm and 980 nm wavelengths (predicate includes 940 nm), maximum 25W working beam output with 650 nm aiming beam, Class IV laser classification, ±5% output stability, multimode laser operation, pulse duration 0.05–99 seconds with ±10% error, and SACS (Selective Aspirating Cutting Suction) operating in air, CO2, or liquid modes with specified flow adjustments. These specifications match the predicate devices except for the minor wavelength difference.

IEC 60601-1 (general safety and essential performance), IEC 60601-2-22 (surgical and therapeutic laser equipment), IEC 60601-1-2 (electromagnetic disturbances and immunity), and IEC 60825-1 (laser product safety and classification). All non-clinical testing was performed to demonstrate compliance with applicable standards.

The proposed device is substantially equivalent because it shares identical product code (GEX), regulation number (21 CFR 878.4810), indications for use, laser type, output power, class, stability, pulse duration, laser mode, and SACS operating parameters with the predicate LASERPRO 810, 940, and 980 systems. The only material difference is wavelength (980/810 nm versus 980/810/940 nm in predicate), which the applicant argues will not result in safety or performance differences. Non-clinical testing demonstrated compliance with the same international standards as the predicate, supporting functional and safety equivalence.