Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The Spirit Hair Removal laser Family is generally intended for dermatological use. The devices are specifically indicated for hair removal, permanent hair reduction by using selective laser energy. The Spirit Hair Removal laser Family is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin. Permanent reduction in hair regrowth is defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The Spirit Hair Removal laser Family is generally intended for dermatological use. The devices are specifically indicated for hair removal, permanent hair reduction by using selective laser energy. The Spirit Hair Removal laser Family is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin. Permanent reduction in hair regrowth is defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The Spirit Hair Removal laser Family has two models of the same device (916, & 918) and several trade names. The devices apply photothermal energy to human skin tissue to effect a desired change in the structure of the tissue. The energy is transmitted from a 810nm laser diode to the target tissue by a Treatment Handpiece that is in contact with the skin. The 918 and 916 models have fully identical HW. The difference in the optical output power (6 -90J/cm2 for the 918 model and 4.5 to 10J/cm2 for the 916 model) is preset. For the hair removal treatment, the devices utilized laser energy at the spectrum of 810nm (IR) which is absorbed by the Melanin which is located in the hair follicles. Once the energy is absorbed, it is turned into heat. The heat coagulates the hair follicles and removes the unwanted hair. The Spirit Hair Removal laser Family was designed to comply with international standards and is constructed from metal, plastic a diode laser and other electronic components.
Summary parsed at:2026-06-01 06:05:36 UTC
