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The Cutera Optional Pulsed Light Hand Piece Family is indicated for use in the surgical, aesthetic and cosmetic applications requiring selective photothermolysis in the medical specialties of general and plastic surgery and dermatology.

The Cutera Optional Pulsed Light Hand Piece Family is intended for the treatment of:

• Tattoos;
• Benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
• Cutaneous lesions including warts, scars and striae;
• Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, roasacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
• Psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis;
• Removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction; and
• Mild to moderate inflammatory acne vulgaris.

The pulsed light delivery hand pieces are comprised of four main components:

• an "umbilica!" cable and connector, that is permanently attached to the hand piece body and is semi-permanently attached to the console system (detachable by positive action from the user) that houses:
• electrical cables (to support the thermoelectric cooler associated with the chilled hand piece tip, to provide power and a trigger source to the xenon flash lamp, to provide detector signals and to connect a memory device that identifies the hand piece);
• a supply and return water line (to remove the heat generated by the flash lamp and thermoelectric cooler);
• the hand piece internals described above; and
• the hand piece housing the internals and connecting to the umbilical.

These hand pieces are accessories to be used on previously cleared Cutera console systems where the 510(k) permitted use of pulsed light (a.k.a. flash lamp) hand pieces.

The provided text is a 510(k) summary for the Cutera Optional Pulsed Light Hand Piece Family. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about a clinical study with acceptance criteria and reported device performance data.

The document states: "The new indications for use are based upon the indications for use for predicate pulsed light device systems. Technologically, the Cutera Optional Pulsed Light Hand Piece Family is substantially equivalent to the listed predicate devices. Therefore the risks and benefits for the Cutera Optional Pulsed Light Hand Piece Family are comparable to the predicate devices. We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of this device."

This explicitly indicates that the submission relies on the established safety and effectiveness of the predicate devices and does not present new study data to demonstrate compliance with specific acceptance criteria for the new device.

Therefore, I cannot fulfill your request for points 1-9 as the necessary information is not present in the provided text.

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