# K150907: Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra

- Pathway: 510(k) (Traditional)
- Applicant: Ellipse A/S
- Decided: Jul 7, 2015 after 95 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: 16 generations back to K943450 (1995). 226 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 232 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140670: Ellipse I2PL+/Ellipse Multiflex+, Ellipse A/S (2014) Summary page 4.
- K122493: Genesisplus, Cutera, Inc. (2013) Summary page 4.
- K033461: Candela Vbeam Pulse Dye Laser System, Candela Corp. (2004) Summary page 4.

## Most influential descendants
- 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
- K180406: Ellipse Ydun (2018), 0 descendants of its own

## Indications for use
Ellipse Nordlys system is intended to be used in dermatology, as tabled below: •Permanent Hair Reduction (defined as the long-term, stable reduction in the number of hairs re-growing 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 •Treatment for Clear Nail defined as: Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.). •Treatment of benign cutaneous lesions, such as warts. •Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue), including - Matrixectomy. - Periungal and subungal warts - Plantar warts.

Source page: https://510kreport.com/device/K150907
Methodology: https://510kreport.com/methodology