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Indications for use for the Pure Laser diode hair removal system with a 810nm applicator include: - · Hair removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. - · Treatment of Pseudo folliculitis Barbae (PFB) - · Use on all skin types (Fitzpatrick I-VI)

The PURE Laser system is a non-invasive diode laser based system used for Hair Removal. The system is based on a single wavelength laser diode built-in a HP, with a 10x10mm spot size and ability to control the pulse width, frequency and power. The Hair Removal Laser is intended for use on all skin types (Fitzpatrick skin types I-VI). The device is sold with an electroconductive gel with prior FDA clearance – EndyGel (K161715).