Manufacturer
Ellipse A/SFrax 1550 for Ellipse 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
- K161162
- Device name
- Frax 1550 for 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
- 2016-04-25
- Decision date
- 2016-09-16
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Hair removalVascular treatmentPigment 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, (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.
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, (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.
Summary parsed at:2026-06-01 06:06:14 UTC
Predicate devices
4—
—
Not ingested
—
—
Not ingested
—
—
Not ingested
Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
K161162 references 4 predicate/reference devices
Cited as predicate
3Ellipse Ydun
MT One
Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun
3 submissions cite K161162 as a predicate
