# K140670: Ellipse I2PL+/Ellipse Multiflex+

- Pathway: 510(k) (Traditional)
- Applicant: Ellipse A/S
- Decided: Sep 25, 2014 after 191 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K943450 (1995). 154 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 161 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060516: Ellipse 12PL, Model 9ESL7228, Danish Dermatologic Development A/S (2006) Summary page 5.
- K081408: Ellipse Multiflex, Ellipse A/S (2008) Summary page 5.
- K041086: Palomar Starlux Pulsed Light System, Palomar Medical Products, Inc. (2005) Summary page 5.
- (no number) Icon™: named in the summary without a submission number
- (no number) Genesisplus Laser System™: named in the summary without a submission number

## Most influential descendants
- 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
- K240474: Multi-function Platform Systems   (BL-M10) (2024), 0 descendants of its own

## Recalls of this device
- May 5, 2016 · Class II · Z-1697-2016: Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.

## Indications for use
Ellipse I2PL+ and Ellipse MultiFlex+ systems are intended to be used in dermatology, as tabled below: - Permanent hair reduction (defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime) (overall 600-950nm). - Treatment of Telangiectasias (530-750nm or 555-950nm). - Treatment of Port Wine Stains (530-750nm or 555-950nm). - Treatment of Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular Lesions (eg Diffuse Redness) (530-750nm or 555-950nm). - Treatment of Rosacea (530-750nm or 555-950nm). - Treatment of Poikiloderma of Civatte (530-750nm or 555-950nm). - Treatment of Benign Epidermal Pigmented Lesions (eg Lentigo Solaris) (400-720nm). - Treatment of Inflammatory Acne vulgaris (530-750nm). Using Nd:YAG laser, (1064nm) (Ellipse MultiFlex+ system, only): - Treatment of Leg vessels (0.1 -3.0mm diameter). - Treatment of Benign Vascular Lesions. - Treatment of Venous Lakes. - Treatment of Port Wine Stains. - Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, efc.).

Source page: https://510kreport.com/device/K140670
Methodology: https://510kreport.com/methodology