# K192483: MeDioStar

- Pathway: 510(k) (Special)
- Applicant: Asclepion Laser Technologies GmbH
- Decided: Mar 13, 2020 after 185 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: 21 generations back to K943450 (1995). 522 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 526 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143519: The MeDioStar NeXT Family, Asclepion Laser Technologies GmbH (2015) Summary page 6.
- K170179: LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity, Lumenis, Ltd. (2017) Summary page 6.

## Most influential descendants
- K240816: MeDioStar (2024), 0 descendants of its own
- K234057: Nirvana (2024), 0 descendants of its own
- K232236: Echo (2023), 0 descendants of its own

## 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/K192483
Methodology: https://510kreport.com/methodology