Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b)

The Leaseir MHR Xcell is a surgical laser system for use in general, plastic surgery, and dermatology. It is intended for permanent hair reduction, treatment of pseudofolliculitis barbae (PFB), and treatment of benign vascular and pigmented lesions on all skin types (Fitzpatrick I-VI). The device uses diode laser technology at 810nm or 810-1060nm wavelengths delivered via interchangeable handpieces in static and dynamic modes.

The device is substantially similar in design, materials, principle of operation, and energy source to its predicates. The minor differences involve two additional applicators (Dual and Quad handpieces) and associated software updates to recognize the new handpiece models and deliver different laser parameters. No changes to the fundamental design, chemical composition, or operational principle were made.

Testing complied with ANSI AAMI ES60601-1:2005, IEC 60601-1-2 Edition 4.0, IEC 62304 Edition 1.1, IEC 60601-2-22 Edition 3.1, IEC 60825-1 Edition 2.0, ISO 14971 Third Edition, and IEC 62366-1 Edition 1.1. Software verification and validation testing was also conducted per FDA guidance on device software.

The subject device is the same or similar in design, intended use, principles of operation, and technological characteristics as the predicate devices (including the primary predicate Leaseir MHR Xcell). The minor differences in offering two additional applicators do not raise new safety or effectiveness questions, and performance testing demonstrates safe and effective use for the proposed indications. The applicant is the owner of the predicate device.