# K111851: Mediostar Next

- Pathway: 510(k) (Special)
- Applicant: Asclepion Laser Technologies GmbH
- Decided: Jul 8, 2011 after 9 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: 1 generation back to K050900 (2005). 2 ancestors in all.
33 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053628: Lightsheer Duet Laser System, Lumenis, Inc. (2006) Summary page 1.
- K050900: Mediostar XT, Asclepion Laser Technologies GmbH (2005) Summary page 1.

## Most influential descendants
- K143519: The MeDioStar NeXT Family (2015), 32 descendants of its own
- 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

## Indications for use
The MeDioStar NeXT laser system is intended for surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery and dermatology. The MeDioStar NeXT laser system is intended for the treatment of vascular lesions. The MeDioStar NeXT laser system is intended for hair removal, permanent hair reduction and the treatment of pigmented lesions.

Source page: https://510kreport.com/device/K111851
Methodology: https://510kreport.com/methodology