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The Profile BBL (and the light and/or laser delivery accessories) is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.
It is intended for use for:
• The treatment of tattoos;
• The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
• The treatment of cutaneous lesions including warts, scars and striae;
• The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, engiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
• Treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis; and
• The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction.
The integral thermo-electric cooler is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
• Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
• Reduce discomfort during and/or associated with light or laser treatment:
• Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation;
• Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and
• Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

Profile BBL System emits intense wide spectrum emission with wavelength of 500-1400 nm. It consists of a system console, internal computer, control panel and display, and a treatment head comprised of a light guide with cooling capability and a pushbutton switch.

The provided text is a 510(k) summary for the Sciton Profile BBL System. It establishes substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

This document focuses on the regulatory aspects of device clearance, asserting equivalence based on similar indications for use, design features, and functional features compared to previously cleared devices. It does not present novel performance data or detail any studies designed to meet specific acceptance criteria for the Sciton Profile BBL System itself.

Therefore, the requested information, such as a table of acceptance criteria and device performance, sample sizes, expert qualifications, ground truth details, or MRMC study results, cannot be extracted from the provided text.

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