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Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of IFB. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin.

Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, hemoangioma, warts, telangiectasia, rosacea, Venus lake, leg veins and spider veins.

Coagulation and hemostasis of soft tissue.

Incision/excision of soft body tissue in dermatology

Soft tissue general surgery applications-skin incision; tissue dissection; compelte or partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation.

Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tatoos) and plaques. The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The laser is also indicated for the reduction of red pigmentation and hypertrophic and keloid scars where vascularity is an integral part of the scar.

Treatment of wrinkles.

The Fotona XP Plus Nd:YAG Family of Laser Systems is a flashlamp-excited, Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet) laser. Pulsed laser energy at a nominal wavelength of 1064 nanometers (nm) is used. This wavelength causes maximum energy absorption by the target (hair or lesion) and minimum absorption by surrounding skin structures. In addition, the laser pulse duration is controlled to be equal to or shorter than the relaxation time of the target, to minim ize heat transfer to surrounding tissues.

Within the system, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided down an optical fiber delivery system to a focusing handpiece. The laser is used in non-contact mode. The Fotona XP Plus Nd: YAG Family of Laser Systems is designed with 5 major sub-systems:

a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.

b) A cooling system consisting of an internal water flow circuit together with water-toair heat exchanger.

c) An Nd: Y AG laser rod, capable of generating optical pulses .

d) An optical delivery system, interfacing the energy from the laser to the patient via an optical fiber and focusing handpiece.

e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification letter from the FDA, determining that the Fotona XP Plus Nd:YAG Family of Laser Systems is substantially equivalent to legally marketed predicate devices.

The letter describes:

• The device name and classification.
• Its intended uses (indications for use).
• A summary of its technology and operating principles.
• A comparison to predicate devices to establish substantial equivalence.

It does not include details about specific performance metrics, acceptance criteria, or a study design with sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The letter asserts "Safety and effectiveness are reasonably assured, therefore justifying 510(k) clearance for commercial sale" based on this substantial equivalence argument, rather than presenting a detailed study with acceptance criteria.

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