PURE Laser - Hair-removal diode laser system

Intended purpose

Indications for use for the PURE Laser diode laser hair removal system with 810nm applicator include: • Hair Removal with Static (Regular) and Dynamic (DioGlide) 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 regime. • Treatment of Pseudo folliculitis barbae (PFB) • Use on all skin types (Fitzpatrick I-VI).