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Ellipse Nordlys system is intended to be used in dermatology, as tabled below: * Permanent Hair Reduction (defined as teh 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

The Frax 1940 applicator is used with the Ellipse Nordlys (K150907 and K161162) and Ellipse Ydun (K180406). The Nordlys and Y dun systems consists of a console containing power unit and control electronics with control and display panel, including software. The Frax 1940 applicator connects to the system and have built in Laser diodes emitting 1940 nm light in a fractionated pattern. The mode of action is delivering a series of light pulses in a row of up to 10 mm as the applicator is moved across the skin. This leaves a pattern of micro dots (Micro Thermal Zone) of irradiated skin, typically in the order of 100 MTZ/cm2. Due to the area of the damaged skin in each MTZ, a certain percentage of the covered skin is affected, and this is referred to as the Coverage (percentage) of the treatment. The control of pulses as the applicator is moved is by a magnetic motion sensor embedded in the roller that also acts as skin distance controlling device. The motion detection and the control of the laser diodes is done in a micro controller embedded in the handpiece. The materials used are the same as the predicate device Frax 1550 (aluminum and ABS), and the applicator is intended to be in contact with the patient for 15-30 minutes. The system is intended to be used in healthcare facilities and hospital environments.

Ellipse Ydun system is intended to be used in dermatology, as tabled below: - Ydun is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

Ellipse Ydun is a platform/console capable of driving the Ellipse Frax 1550 applicator, which is a 1550 nm Laser diode-based applicator cleared by FDA under K161162. The Ydun system consists of a console containing power unit and control electronics with control and display panel, including software. The Frax 1550 applicator connects to the system and have built in Laser diodes emitting 1550 nm light in a fractionated pattern.

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 555-950mm). - · Treatment of Port Wine Stains (530-750nm or 555-950nm). · Treatment of Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular Lesions (ex Diffuse Redness) (530-750nm or 555-950nm). - · Treatment of Rosacea (530-750nm or 555-950nm). - · Treatment of Poikiloderma of Civatte (530-750nm or 555-950mm). - · Treatment of Benign Epidermal Pigmented Lesions (eg Lentigo Solaris) (400-720nm). - · Treatment of Inflammatory Acne Vulgaris (530-750mm). 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.

Ellipse Nordlys is an Intense Pulsed Light (IPL) and Laser system (Nd:YAG 1064 nm and Fractional 1550 nm) used for long-term removal of unwanted hair; for treatment of sun-damaged skin, including uneven pigmentation, age spots, large pores, diffuse redness, and for the treatment of telangiectasias, port wine stains, rosacea, poikiloderma of civatte and inflammatory acne in the area of dermatology. The systems consist of a console containing power unit and control electronics with control and display panel including software. IPL Applicators/hand-pieces are connected to the systems in order to generate light energy for treatment in the waveband 400 nm - 950 nm. Additionally a Nd:Y AG hand piece (1064 nm) and a Fractional (1550 mm) hand piece can be connected to the Ellipse Nordlys for treatment of: Vascular lesions as stated below under Intended Use/Indications for Use for the Nd: YAG and fractional treatments for non-ablative skin resurfacing for Frax 1550 as stated below.

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 555-950mm). · Treatment of Port Wine Stains (530-750nm or 555-950nm). · Treatment of Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular Lesions (ex Diffuse Redness) (530-750nm or 555-950nm). · Treatment of Rosacea (530-750nm or 555-950mm). · 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 (530-750mm). · Using Nd: Y AG 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.

Ellipse Nordlys is an Intense Pulsed Light (IPL) and Nd:YAG Laser system used for long-term removal of unwanted hair; for treatment of sun-damaged skin, including uneven pigmentation, age spots, large pores, diffuse redness, and for the treatment of telangiectasias, port wine stains, rosacea, poikiloderma of civatte and inflammatory acne in the area of dermatology. The systems consist of a console containing power unit and control electronics with control and display panel including software. IPL Applicators/hand-pieces are connected to the systems in order to generate light energy for treatment in the waveband 400 nm - 950 nm. Additionally a Nd: YAG handpiece (1064 nm) can be connected to the Ellipse Nordlys for treatment of vascular lesions as stated below under Intended Use/Indications for Use.

Ellipse I2PL+ and Ellipse MultiFlex+ systems are intended to be used in dermatology, as tabled below: - Permanent hair reduction (defined as the long-term, stable reduction in the number of hairs regrowing 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 Diffüse 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 (530-750mm). 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. - Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

Ellipse PPL+ and Ellipse Multiflex+ are identical Intense Pulsed Light (IPL) systems used for long-term removal of unwanted hair; for treatment of sun-damaged skin, including uneven pigmentation, are spots, diffuse redness, and for the treatment of telangiectasias, port wine stains, rosacea, poikiloderma of civatte and inflammatory acne in the area of dermatology. The systems consist of a console containing power unit and control electronics with control and display panel including software. IPL Applicators/hand-pieces are connected to the systems in order to generate light energy for treatment in the waveband 400 nm - 950 nm. Additionally a Nd: YAG handpiece (1064 nm) can be connected to the Ellipse MultiFlex+ for treatment of vascular lesions as stated below under Intended Use/Indications for Use.

Ellipse MultiFlex is intended for use in dermatology. Ellipse MultiFlex used with IPL applicators (9APP7133, 7116, 7114, 7134, 7212, 7377, 7213): - Hair removal (permanent hair reduction). - Treatment of benign pigmented lesions (including, but not limited to solar lentigines, ephilides, mottled pigmentation) and benign vascular lesions (including but not limited to diffuse redness, telangiectasias, port wine stains). - Treatment of inflammatory acne. Ellipse MultiFlex used with Nd: YAG applicator (9APP7472): - Treatment of leg vessels (0.1 3.0 mm diameter).

Ellipse Multiflex is an Intense Pulsed Light (IPL) system used for long-term removal of unwanted hair; for treatment of sun-damaged skin, including uneven pigmentation, age spots, large pores, diffuse redness, and for the treatment of telangiectasias, port wine stains and inflammatory acne in the area of dermatology, The system consists of a console containing power unit and control electronics with control and display panel including software. IPL Applicators/hand-pieces are connected to the system in order to generate light energy for treatment in the waveband 400 nm - 950 nm. Additionally a Nd:YAG handpiece (1064 nm) can be connected to the Ellipse MultiFlex for treatment of vascular lesions as stated under Intended Use.

Ellipse Juvia is intended for use in dermatology and plastic surgery for treatment of: - Skin Resurfacing . - Wrinkles, Rhytides, and Furrows . - Acne Scars .

The Ellipse Juvia system comprises the following major parts: - A laser console containing a CO2 laser module capable of providing a laser beam having a . wavelength of 10,600 nm. - A scanner that is intended to manipulate and place a pulsed beam received from the laser . console in a pre-specified pattern on the skin being treated. - An optical fiber providing a beam path from the laser to the scanner. .