Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
STARDUST MED is indicated for use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical field of dermatology and general and plastic surgery. STARDUST MED is indicated for hair removal and permanent hair reduction. Permanent hair reduction is defined as the long term, stable reductions in the number of hairs when measured at 6, 9 and 12 months after the completion of a treatment regime.
STARDUST MED is indicated for use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical of dermatology and general and plastic surgery. STARDUST MED is indicated for hair removal and permanent hair reduction. Permanent hair reduction is defined as the long term, stable reductions in the number of hairs when measured at 6, 9 and 12 months after the completion of a treatment regime.
STARDUST MED is a laser emitting device that is operated with handpiece in contact with the skin. STARDUST MED comprises a main console unit and a handpiece that is triggered by means of footswitch or a finger switch. A microprocessor based system controller is used to monitor and direct all the system function and the graphic user interface. The main console can be connected to the following handpiece: - 808 nm Laser diode.
Summary parsed at:2026-06-01 05:47:58 UTC
MT One Diamond
K200736 references 1 predicate/reference device
No later 510(k)s cite this device yet
Other submissions will appear here when they list K200736 as a predicate
