# K060516: Ellipse 12PL, Model 9ESL7228

- Pathway: 510(k) (Abbreviated)
- Applicant: Danish Dermatologic Development A/S
- Decided: May 15, 2006 after 77 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: 9 generations back to K910422 (1992). 61 ancestors in all.
12 later devices descend from it; 5 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043255: Ellipse Light SPT, Danish Dermatologic Development A/S (2005) Summary page 1.
- K052688: Ellipse Flex PPT, Model 9ESF7255, Danish Dermatologic Development A/S (2005) Summary page 1.

## Most influential descendants
- K140670: Ellipse I2PL+/Ellipse Multiflex+ (2014), 6 descendants of its own
- K150907: Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra (2015), 5 descendants of its own
- K161162: Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra (2016), 4 descendants of its own
- K192856: MT One (2020), 2 descendants of its own
- K203395: Platform treatment system (2022), 1 descendant of its own

## Indications for use
Ellipse I 2PL is intended for use in dermatology: * Hair removal (permanent hair reduction). * Treatment of benign pigmented lesions (including, but not limited to solar lentigines, ephilides, mottled pigmentation) and benign vascular lesions (including but not limited to diffuse redness, telangiectasias, port wine stains). * Treatment of inflammatory acne.

Source page: https://510kreport.com/device/K060516
Methodology: https://510kreport.com/methodology