# K240816: MeDioStar

- Pathway: 510(k) (Special)
- Applicant: Asclepion Laser Technologies GmbH
- Decided: Apr 23, 2024 after 29 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K943450 (1995). 523 ancestors in all.
No later device cites it as a predicate yet.
0 of 524 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192483: MeDioStar, Asclepion Laser Technologies GmbH (2020) Summary page 5.

## 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..

Source page: https://510kreport.com/device/K240816
Methodology: https://510kreport.com/methodology