Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)

The Medical Diode Laser Systems (five models: VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) are infrared diode lasers (810nm and/or 980nm wavelengths) intended to emit energy for topical heating to relieve minor muscle and joint pain, muscle spasm, arthritis pain, and promote muscle relaxation and local blood circulation. The VELAS II-30B model additionally is indicated for temporary increase of clear nail in patients with onychomycosis.

The proposed devices use GaAlAs diode bars at 810nm±10nm and/or 980nm±10nm wavelengths with output power ranging from 0.1W to 30W depending on model. Key differences from predicates include: operation modes (pulse, single pulse, repeat pulse versus continuous wave only), pulse width ranges (10ms-1s and 25μs-10s depending on model), variable pulse repetition rates (0.5Hz-50KHz depending on model), fiber transmission systems (600μm diameter), and aiming beam power (≤2mW or <5mW). Most other parameters including spot diameter, working distance, treatment angle, and non-contact delivery method are identical to predicates.

IEC 60601-1:2005/AMD1:2012/AMD2:2020 (general electrical safety), IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility), IEC 60825-1:2014 (laser safety classification), IEC 60601-2-22:2019 (surgical and therapeutic laser equipment), and IEC 60601-1-6:2010/AMD1:2013/AMD2:2020 (usability). Software verification and validation testing was conducted for moderate-level concern software.

The proposed devices are substantially equivalent because they employ the same diode laser technology at identical or overlapping wavelengths as legally marketed predicates (VELAS II Therapy Laser System K142078, Aspen Laser Systems K150138, Diowave K121363, and prior Gigaalaser models K230047). The indicated uses for therapeutic heating and onychomycosis treatment are identical to or covered by predicate devices. While operational differences exist (pulse modes, adjustable repetition rates, fiber sizes), these represent enhancements that provide lower energy density in pulse mode (safer than continuous wave) and do not raise new safety or effectiveness questions. Energy density, power density, and output power remain within or overlapping predicate device ranges. The non-contact treatment method, handpiece delivery, and working parameters are substantially identical, demonstrating functional and technological equivalence.