# K180406: Ellipse Ydun

- Pathway: 510(k) (Special)
- Applicant: Ellipse A/S
- Decided: Mar 15, 2018 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: 19 generations back to K910422 (1992). 349 ancestors in all.
No later device cites it as a predicate yet.
0 of 350 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161162: Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra, Ellipse A/S (2016) Summary page 4.

## Indications for use
Ellipse Ydun system is intended to be used in dermatology, as tabled below: * Ydun is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

Source page: https://510kreport.com/device/K180406
Methodology: https://510kreport.com/methodology