Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
Indications for use for Eneka Pro diode laser hair removal system with 808nm applicators include: • Hair Removal with Dynamic (DHR) and Fast Dynamic (FDHR) mode 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 Pseudofolliculitis barbae (PFB). • Use on all skin types (Fitzpatrick I-VI)
Indications for use for Eneka Pro diode laser hair removal system with 808nm applicators include: • Hair Removal with Dynamic (DHR) and Fast Dynamic (FDHR) mode 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 Pseudofolliculitis barbae (PFB). • Use on all skin types (Fitzpatrick I-VI)
The Eneka Pro is a non-invasive diode laser based system used for Hair Removal. The system is based on a single wavelength diode laser with 2 handpieces (spot sizes 20x9mm and 34x14mm) and the 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).
Summary parsed at:2026-06-01 05:32:18 UTC
