MeDioStar

Asclepion Laser Technologies GmbH

Country / region:United States (US)Submission type:Special

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

3

Cited as predicate

3

Device details

FDA 510(k) registration fields

K number
K192483
Device name
MeDioStar
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2019-09-10
Decision date
2020-03-13
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 MeDioStar is a pulsed diode laser emitting a wavelength of 750 - 950 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.

Summary parsed at:2026-06-01 05:46:52 UTC

Predicate devices

3

K192483 references 3 predicate/reference devices

Cited as predicate

3

3 submissions cite K192483 as a predicate