Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)

The Medical Diode Laser (Models MZ-GK, MZ-K20, MZ-N75) is a surgical laser system that delivers infrared laser energy at wavelengths of 980nm, 1470nm, or 1940nm (depending on model) in continuous or pulsed modes for soft tissue vaporization, incision, excision, ablation, and hemostasis. It is indicated for use across multiple surgical specialties including urology, thoracic surgery, plastic surgery, dermatology, and general surgery, with specific models supporting endovenous occlusion of the saphenous vein and laser-assisted lipolysis.

The subject device employs the same diode laser technology (980nm, 1470nm, 1940nm) as the predicate devices with identical output parameters and operation modes (continuous wave and pulsed). Primary differences include: (1) dual aiming beam options (green 532nm or red 650nm versus red-only in predicates), though power levels remain within predicate ranges; (2) slightly smaller dimensions and lower weight for the MZ-GK model (28.8cm L × 27.8cm W × 11.5cm H, ≤5 kg versus 29cm × 25cm × 13cm, ≤8 kg for predicates). All models maintain identical power supplies, LCD touchscreen interfaces, fiber delivery systems, and air cooling methods.

IEC 60601-1:2005+AMD1:2012+AMD2:2020 (general safety and essential performance); IEC 60601-1-2:2014+A1:2020 (electromagnetic disturbances); IEC 60601-2-22:2019 (surgical laser equipment safety); IEC 60825-1:2014 (laser product safety and classification). Software verification and validation testing was conducted per FDA's guidance on device software function at the Basic Documentation Level.

The subject device incorporates identical diode laser technology and output parameters as the predicate devices (M2-GK, L2, M2), with indications for use that are substantially the same across all models. The minor differences—dual aiming beam wavelengths and slightly reduced dimensions—do not raise new safety or effectiveness questions because: (1) aiming beam power remains within predicate ranges and meets the same IEC standards; (2) mechanical performance differences comply with IEC 60601-1 and do not affect basic design principles; (3) all devices employ the same laser diode technology and operational characteristics to achieve identical surgical functions. Bench testing confirms the subject device meets accuracy specifications and relevant consensus standards, establishing substantial equivalence without new safety concerns.