Asclepion Laser Technologies GmbH
Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The MeDioStar NeXT Family laser system is intended for surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery and dermatology. The MeDioStar NeXT Family laser system is intended for the treatment of benign vascular lesions. The MeDioStar NeXT Family laser system is intended for the treatment of benign pigmented lesions. The MeDioStar NeXT Family laser system is intended for hair removal, permanent hair reduction defined as reduced hair growth with or without maintenance when measured at 6, 9 and 12 months.
The MeDioStar NeXT Family laser system is intended for surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery and dermatology. The MeDioStar NeXT Family laser system is intended for the treatment of benign vascular lesions. The MeDioStar NeXT Family laser system is intended for the treatment of benign pigmented lesions. The MeDioStar NeXT Family laser system is intended for hair removal, permanent hair reduction defined as reduced hair growth with or without maintenance when measured at 6, 9 and 12 months.
The MeDioStar NeXT and the MeDioStar NeXTPRO (The MeDioStar NeXT Family) are pulsed diode lasers emitting a wavelength of 755 - 950 nm, that are operated with a handpiece in contact with the skin. The lasers are a modification to previously cleared MeDioStar NeXT K111851. All systems comprise a main console unit, a handpiece and are triggered by means of a footswitch. There are several handpieces, the user can choose from.
Summary parsed at:2026-06-01 06:10:40 UTC
