# K050900: Mediostar XT

- Pathway: 510(k) (Special)
- Applicant: Asclepion Laser Technologies GmbH
- Decided: May 16, 2005 after 35 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
No predicates in its family tree.
127 later devices descend from it; 2 cite it directly.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MeDioStar H Laser System (with and without skin cooling system): named in the summary without a submission number

## Most influential descendants
- K083848: Alma Lasers Soprano XL Multi-Application Platform (2009), 125 descendants of its own
- K102716: Modified Alma Lasers Family of Soprano XL Multi-Application Platmforms (2010), 124 descendants of its own
- K112031: Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family of Soprano XL Multi-Application (2011), 118 descendants of its own
- K140009: Soprano Ice Multi-Application & Multi-Technology Platform (2014), 57 descendants of its own
- K123483: Diode Laser (2013), 53 descendants of its own

## Indications for use
The MeDioStar XT Laser System is intended to remove unwanted body hair and vascular lesions.

Source page: https://510kreport.com/device/K050900
Methodology: https://510kreport.com/methodology