Medical diode laser systems (CHARISMA, REGAL)

The Medical Diode Laser System (CHARISMA and REGAL models) is a 1470nm GaAlAs diode laser for surgical and dermatological procedures. CHARISMA is indicated for skin resurfacing, treatment of pigmented lesions, wrinkles, soft tissue incision/excision/ablation, vein occlusion, and laser-assisted lipolysis. REGAL is indicated for soft tissue procedures, vein occlusion, and lipolysis.

Both models use 1470nm diode lasers with output power 0.5–15W (CHARISMA general mode) or 1–15W (REGAL), pulse widths of 10ms–2.5s, and repetition rates of 0.2–50Hz. CHARISMA includes a BeautyScan mode with scanning galvanometer, up to 70 microbeams, and 5×5–18×18mm applicator windows. All models feature fiber delivery, color LCD touch-screen interfaces, and identical laser classification and wavelength to predicates.

IEC60601-1:2005/(R)2012 (medical electrical equipment general safety), IEC60601-1-2:2014-02 (electromagnetic compatibility), IEC60825-1:2007-03 (laser product safety classification), and IEC60601-2-22:2012-10 (surgical/cosmetic laser equipment performance).

The subject device shares identical intended use, product code (GEX), classification (Class II), laser type, and wavelength with multiple predicates (LaserME, Fotona SkyPulse, Alma Diode, VELAS II-15D). Parameter differences in output power, pulse width, and repetition rate fall within or overlap predicate ranges and do not raise new safety or effectiveness questions. Non-clinical testing confirms conformance to applicable standards. The BeautyScan mode parameters (energy density, microbeam count) match predicate K230077 exactly.