The Alma Lasers Soprano Titanium Laser System consists of:•System console (contains the laser diodes, the system software, power supply, andvarious other electronic and mechanical parts)•Operator control panel with touch-screen technology (GUI)•Trio applicator with 1064 nm, 810 nm and 755 nm wavelengths applied simultaneouslyPremarket Notification Traditional 510(k) Section 8: Page 2 of 4Alma Lasers Soprano Titanium• 810 nm applicator• 755 nm applicator• Small NIR applicator• Footswitch and other laser safety accessories
A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to remove unwanted body hair (e.g., armpit, leg/arm, back, chest, bikini line, and face). It is intended to be used by a trained professional to emit pulsed light of a wavelength around 808 nm, delivered by a dedicated handpiece, to destroy hair follicles by heat. Also known as a laser epilator, it typically includes a control unit with dedicated software and user interface, delivery handpiece, and foot-switch.