Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)

The Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) is a dual-wavelength laser device operating at 755nm and 1064nm. It is indicated for temporary and permanent hair reduction, treatment of benign pigmented lesions, vascular lesions (port-wine stains, telangiectasias), wrinkles, and temporary treatment of onychomycosis across all skin types (Fitzpatrick I-VI).

The proposed device uses Alexandrite and Nd:YAG lasers with spot sizes of 6/8/10/12/15/18mm, pulse duration of 0.7-20ms, frequency of 0.5-2Hz, and maximum output energy of 50J (755nm) and 80J (1064nm). It features closed-loop water cooling, footswitch control, and supports AC 120V/60Hz and AC 230V/50Hz power inputs. Key differences from the predicate include narrower spot size range and different cooling method (water vs. spray), but all parameters remain within safe and effective operating ranges.

The device complies with ISO 10993-5, ISO 10993-10, ISO 10993-23 (biocompatibility); IEC 60601-1 Edition 3.2, IEC 60601-1-2 Edition 4.1, IEC 60601-2-22 Edition 4.0 (medical electrical equipment safety); and IEC 60825-1:2014 (laser safety).

The proposed device is substantially equivalent to the SANDRO Dual (K200110) predicate because both are dual-wavelength Alexandrite and Nd:YAG laser systems with identical indications for use, same laser classification (Class IV), identical wavelengths (755/1064nm), same maximum energy outputs, and compliance with the same applicable safety standards. Minor design variations (spot sizes, pulse duration, cooling method, electrical inputs) fall within acceptable ranges demonstrated by passing all required IEC and ISO standards testing.