Manufacturer
Asclepion Laser Technologies GmbHMeDioStar
Asclepion Laser Technologies GmbH
Country / Region:United States (US)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K240816
- Device name
- MeDioStar
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-03-25
- Decision date
- 2024-04-23
- Submission type
- Special
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removalPigment treatmentVascular treatment
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The MeDioStar laser system is intended for surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery and dermatology. The MeDioStar laser system is intended for the treatment of benign vascular lesions. The MeDioStar laser system is intended for the treatment of benign pigmented lesions. The MeDioStar 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.
Intended Use
The MeDioStar laser system is intended for surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery and dermatology. The MeDioStar laser system is intended for the treatment of benign vascular lesions. The MeDioStar laser system is intended for the treatment of benign pigmented lesions. The MeDioStar 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.
Device Description
The modified MeDioStar is a pulsed diode laser emitting a wavelength of 755 - 1060 nm that is operated with a handpiece in contact with the skin. The system comprises a main console unit, a handpiece and is triggered by means of a footswitch. There are several handpieces, the user can choose from. Moreover, a specific software controls the device functions and allows the user selections through the touchscreen display. The laser is a modification to previously cleared MeDioStar due to some technical modifications concerning the wavelength range.
Summary parsed at:2026-06-01 05:28:04 UTC
Predicate devices
2LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
MeDioStar
K240816 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K240816 as a predicate
