Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
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)
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).
Summary parsed at:2026-06-01 05:40:20 UTC
