Diode laser system (Night Universe; Predator)

The Diode Laser System (Night Universe; Predator) is an 810nm diode laser used for professional hair removal and rapid hair removal in two modes (HR and FHR). It is intended for permanent hair reduction on all skin types (Fitzpatrick I-VI) including tanned skin, with permanent reduction defined as stable hair reduction measured at 6, 9, and 12 months post-treatment.

The device operates at 810nm wavelength with energy density HR: 2-60 J/cm², FHR: 2-10 J/cm², spot size of 2 cm², pulse width 5-200ms, and frequency HR: 1-3Hz, FHR: 5-10Hz. Minor differences include water+air cooling (versus predicate cooling methods), weight of 33-60kg, and sizes of 350×450×1000mm or 500×600×500mm. These dimensional and cooling differences are not expected to affect safety or effectiveness.

IEC 60601-1:2005+A1:2012+A2:2020 (general medical device safety), IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility), IEC 60601-2-22:2007+A1:2012 (surgical laser equipment), IEC 60825-1:2014 (laser product safety), ISO 10993-5:2009 (cytotoxicity), and ISO 10993-10:2010 (irritation and hypersensitivity).

The device has identical technological characteristics to predicates K222064 (Alma Soprano Titanium) and K123483 (Diode Laser) in all critical parameters: wavelength, energy density, operation modes, spot size, laser type, pulse width, and frequency. Minor differences in cooling mechanism, weight, and physical dimensions do not raise new safety or effectiveness issues and do not affect clinical performance. All versions comply with the same IEC and ISO standards, demonstrating equivalent safety profile and performance to legally marketed predicates.