# K081408: Ellipse Multiflex

- Pathway: 510(k) (Traditional)
- Applicant: Ellipse A/S
- Decided: Oct 17, 2008 after 151 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: 14 generations back to K943450 (1995). 152 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 160 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060448: Lumenis One Family of Systems; Lumenis One., Lumenis, Ltd. (2006) Summary page 1.
- K033946: Lovely System, Msq (M2), Ltd. (2004) Summary page 1.
- K041879: Palomar LUX1064 Handpiece, Palomar Medical Technologies, Inc. (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 MultiFlex is intended for use in dermatology. Ellipse MultiFlex used with IPL applicators(9APP7133, 7116, 7114, 7134, 7212, 7377, 7213): * 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. Ellipse MultiFlex used with Nd;YAG applicator(9APP7472): * Treatment of leg vessels (0.1 - 3.0 mm diameter).

Source page: https://510kreport.com/device/K081408
Methodology: https://510kreport.com/methodology