Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun

Ellipse A/S

Country / region:Denmark (DK)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Denmark (DK)

Product code

GEX
21 CFR 878.4810

Predicate devices

4

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K192951
Device name
Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun
Country / region
Denmark(DK)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2019-10-21
Decision date
2020-03-26
Submission type
Traditional
Technology type
Er:YAG(AI inferred)
Clinical applications
Hair removalVascular treatmentPigment treatmentSkin resurfacing
Primary application
Hair removal
Classification source
AI classified

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 - 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 (e.g., Mottled Pigmentation, Ephilides) and Benign Vascular Lesions (e.g., 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 (e.g., 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

Intended 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 - 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.

Device Description

performance, intended use/indications for use, to the

Summary parsed at:2026-06-01 05:47:08 UTC

Predicate devices

4
  • K130193

    Not ingested
  • K150907

    Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra

    Ellipse A/S

  • K161162

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

    Ellipse A/S

  • K180406

    Ellipse Ydun

    Ellipse A/S

K192951 references 4 predicate/reference devices

Cited as predicate

1

1 submission cite K192951 as a predicate