Manufacturer
Ellipse A/SEllipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun
Country / Region:Denmark (DK)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K192951
- Device name
- Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun
- Company
- Ellipse A/S
- 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—
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Not ingested
Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
Ellipse Ydun
K192951 references 4 predicate/reference devices
Cited as predicate
1Frax 1940 for Nordlys and Frax Pro
1 submission cite K192951 as a predicate
