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

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

3

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
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
  • K080932

    Not ingested
  • K130193

    Not ingested
  • K142376

    Not ingested
  • K150907

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

    Ellipse A/S

K161162 references 4 predicate/reference devices

Cited as predicate

3

3 submissions cite K161162 as a predicate