# K161162: Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra

- Pathway: 510(k) (Traditional)
- Applicant: Ellipse A/S
- Decided: Sep 16, 2016 after 144 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: 18 generations back to K910422 (1992). 348 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 353 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150907: Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra, Ellipse A/S (2015) Summary page 5.
- K142376: Palomar Icon Aesthetic System, Cynosure, Inc. (2014) Summary page 5.
- K130193: Fraxel Dual 1550/1927 Laser System, Solta Medical, Inc. (2013) Summary page 5.
- K080932: Mosaic Laser System, Lutronic Corporation (2008) Summary page 6.
- K130028: Resurfx 1565NM Laser Module, Lumenis, Ltd. (2013) Summary page 6.

## Most influential descendants
- 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, (1064 nm): • Treatment of Leg vessels (0.1 -3.0 mm 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. Using Frax 1550 Laser, (1550 nm): • The Frax 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

Source page: https://510kreport.com/device/K161162
Methodology: https://510kreport.com/methodology