Sanhe Laserconn Tech Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) is a solution for fast hair removal with 810nm±10nm high power laser diodes. They are designed with TEC and sapphire cooling unit for skin contact. The laser beam is sublimated with a patented technology of beam shaping for a high efficiency for hair removal solution. This diode laser hair removal can be used for Fitzpatrick skin type I-VI. The pulse energy is up to 40J/cm².
Summary parsed at:2026-06-01 05:40:31 UTC
