Manufacturer
Ellipse A/SEllipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
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
- K150907
- Device name
- Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
- Company
- Ellipse A/S
- Country / Region
- Denmark(DK)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2015-04-03
- Decision date
- 2015-07-07
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Hair removalVascular treatment
- 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 600-950nm). • 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.
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 600-950nm). •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, and Plantar warts.
Device Description
The Ellipse Nordlys system is an Intense Pulsed Light (IPL) and Laser system that includes Nd:YAG handpieces/applicators. It operates in the waveband 400 nm – 950 nm and is designed for various dermatological treatments as specified in the intended use section.
Summary parsed at:2026-06-01 06:11:04 UTC
Predicate devices
3Cited as predicate
3Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
MT One
Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun
3 submissions cite K150907 as a predicate
