(144 days)
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.
The provided text is a 510(k) summary for the Ellipse Nordlys system with the Frax 1550 hand piece. This document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance. It does not contain a detailed study report with specific acceptance criteria and performance data for a new AI/algorithmic device.
Instead, it states that the device complies with various performance standards and that technical parameters are "as safe and effective as the predicate devices."
Therefore, I cannot extract the requested information in the format provided because the document describes a laser device and its regulatory clearance process, not an AI or algorithmic medical device that would have specific performance metrics like sensitivity, specificity, or ROC AUC from a clinical study.
The document mentions:
- Performance Standards utilized: IEC 60601-1, IEC 60601-2-57, IEC 60825-1, IEC 60601-2-22, IEC 60601-1-2, US FDA 21 CFR 1040.10 and 1040.11 for Class IV Laser Products, European Medical Device Directive 93/42/EEC (Annex II), and ISO13485 Quality Management System.
- Performance Data: "Testing certificates by UL International and Delta according to above listed Performance Standards were provided which demonstrates that Ellipse Nordlys with the listed applicators/handpieces utilize technical parameters which are as safe and effective as the predicate devices."
- Study for Frax 1550 settings: "The default start settings for the Frax 1550 are based on the most relevant clinical investigations found to be safe and effective in the Ellipse literature study (RA18704, appendix 2) and equivalent to what are used as standard settings for the same treatments for Frax SR1550 (K130193) and Icon Lux1540 (K142376)." This refers to a literature study to justify parameter settings, not a new clinical study.
Without a detailed clinical study report specifically for an AI/algorithmic device, I cannot fill in the requested table and details.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.