# K192951: Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun

- Pathway: 510(k) (Traditional)
- Applicant: Ellipse A/S
- Decided: Mar 26, 2020 after 157 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: 13 generations back to K910422 (1992). 132 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 134 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130193: Fraxel Dual 1550/1927 Laser System, Solta Medical, Inc. (2013) Summary page 5.

## Most influential descendants
- K212492: Frax 1940 for Nordlys and Frax Pro (2021), 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 teh 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 - 950 nm). * Treatment of Telangiectasias (530-750 nm or 555-950 nm) * Treatment of Port Wine Stains (530-750 nm or 555-950 nm) * Treatment of Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular Lesions (eg Diffuse Redness) (530-750 nm or 555-950 nm) * Treatment of Rosacea (530-750 nm or 555-950 nm) * Treatment of Poikiloderma of Civatte (530-750 nm or 555-950 nm) * Treatment of Benign Epidermal Pigmented Lesions (eg Lentigo Solaris)(400-720 nm) * Treatment of Inflammatory Acne Vulgaris (530-750 nm) Ellipse Nordlys + 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, and coagulation of soft tissue), including: - Matrixectomy - Periungal and subungal warts - Plantar warts. Ellipse Nordlys + 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. Ellipse Nordlys + Frax 1940 Laser (1940 nm): * The Frax 1940 nm Laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures. Ellipse Ydun system is intended to be used in dermatology, as tabled below: Ellipse Ydun + Frax 1550, (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. Ellipse Ydun + Frax 1940, (1940 nm) *The Frax 1940 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures

Source page: https://510kreport.com/device/K192951
Methodology: https://510kreport.com/methodology