Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The Global Med Systems Milesman Compact Laser is intended for use in dermatological and general surgical procedures including hair removal and permanent hair reduction. 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 regimen. It is intended for use on all skin types (Fitzpatrick skin types 1-VI), including tanned skin.
The Global Med Systems Milesman Compact Laser is intended for use in dermatological and general surgical procedures including hair removal and permanent hair reduction. 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 regimen. It is intended for use on all skin types (Fitzpatrick skin types 1-VI), including tanned skin.
The Global Med Systems Milesman Compact Laser delivers pulsed laser energy at 810 nm to the surface of the skin using a handpiece which contains the laser diodes. The Milesman Compact consists of the following components: 1. The main console unit 2. Handpiece 3. Umbilical (between main console and handpiece) 4. Footswitch. The system is operated using the touch screen on top of the main console unit. Firing of the laser is controlled with either the footswitch or the trigger on the handpiece. During hair removal, the laser emits a wavelength of light that is absorbed by the pigment (melanin) in the hair. The light energy is converted to heat, which damages the tube-shaped sacs within the skin (hair follicles) that produce the hair. This damage inhibits or delays future hair growth. The face of the hand piece which comes into contact with skin is actively cooled with a circulating coolant fluid.
Summary parsed at:2026-06-01 05:42:32 UTC
