Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)

The Medical Diode Laser Systems (models GBOX-6H, GBOX-10D, GBOX-12D, GBOX-15D, VELAS II-6H, VELAS II-15D, VELAS Pro-30B15D) are surgical laser devices used for vaporization, incision, excision, ablation, cutting, and hemostasis of soft tissue across multiple surgical specialties including urology, plastic surgery, dermatology, and general surgery. Some models are also indicated for endovenous occlusion of the greater saphenous vein and laser-assisted lipolysis.

The devices use GaAlAs diode laser technology at wavelengths of 1940nm, 1470nm, or 980nm depending on model. Key operational features include continuous wave and pulsed modes, color LCD touch screen interface, output power ranging from 1–6W to 1–15W, pulse widths of 10ms–10s (or 10ms–1s for VELAS Pro-30B15D), repetition rates of 0.05–50Hz, and red aiming beams. All are Class 4 lasers powered by 100–240 VAC, 50–60Hz supplies.

Testing per IEC60601-1:2005(R)2012 (electrical safety), IEC60601-1-2:2020-09 (electromagnetic compatibility), IEC60825-1:2007-03 (laser product safety), IEC60601-2-22:2012-10 (surgical laser equipment), and IEC60601-1-6:2020-07 (usability). Software verification and validation per FDA guidance for software in medical devices.

The proposed devices are substantially equivalent because they employ the same diode laser operating principle and wavelengths as predicate devices (MANTA, SkyPulse, Alma, and M2-GK models), with identical or substantially similar intended uses and operational modes. While output power, pulse width, and repetition rate specifications differ slightly between models, these differences fall within the ranges claimed by predicate devices and do not alter suitability for intended use. The fiber contact materials are previously approved (K140470), and non-clinical testing demonstrates safety and performance equivalent to legally marketed predicates.