# K143519: The MeDioStar NeXT Family

- Pathway: 510(k) (Special)
- Applicant: Asclepion Laser Technologies GmbH
- Decided: Mar 10, 2015 after 88 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: 20 generations back to K943450 (1995). 516 ancestors in all.
32 later devices descend from it; 4 cite it directly.
0 of 549 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111851: Mediostar Next, Asclepion Laser Technologies GmbH (2011) Summary page 5.
- K140009: Soprano Ice Multi-Application & Multi-Technology Platform, Alma Lasers, Ltd. (2014) Summary page 5.

## Most influential descendants
- K180719: InMode Diolaze System (2018), 13 descendants of its own
- K152714: Quanta Forte (2015), 13 descendants of its own
- K191321: Primelase Excellence (2019), 8 descendants of its own
- K172413: MT ONE (2017), 5 descendants of its own
- K192539: Deka Luxea (2019), 4 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K143519
Methodology: https://510kreport.com/methodology