# K072023: Ellipse Juvia, Model 9EJU7465

- Pathway: 510(k) (Traditional)
- Applicant: Ellipse A/S
- Decided: Sep 12, 2007 after 51 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: 5 generations back to K936109 (1994). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022060: Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories, Lumenis, Inc. (2002) Summary page 1.
- K063001: Slim Evolution Family of CO2 Lasers and Delivery Device Accessories, Lasering S.R.L. (2007) Summary page 1.

## Indications for use
Ellipse Juvia is intended for use in dermatology and plastic surgery for treatment of: * Skin Resurfacing * Wrinkles, Rhytides, and Furrows * Acne Scars

Source page: https://510kreport.com/device/K072023
Methodology: https://510kreport.com/methodology