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The Medical Picosecond ND:YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:

1064nm wavelength:

• Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

532nm wavelength:

• Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

The Medical Picosecond ND: YAG Laser System mainly consists of a host, a light guide arm, a treatment handle, a foot switch, a power cord, and other auxiliary treatment accessories. The host mainly includes laser power supply, laser, water circulation cooling system, control board, and display screen. Accessories include a foot switch, laser protective glasses, power cords, and a water filling funnel.

The Medical Picosecond ND: YAG Laser System is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm).

I am sorry, but the provided FDA 510(k) clearance letter for the Medical Picosecond ND: YAG Laser System (PZ-6) does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document states:

• "No clinical study is included in this submission." (Page 11, Section 8.0 Clinical Test Conclusion)
• The "Non clinical tests were conducted to verify that the subject devices met all design specifications as were Substantially Equivalent (SE) to the predicate device." (Page 11, Section 7.0 Non-Clinical Test Conclusion) These non-clinical tests relate to compliance with various IEC and ISO standards for medical electrical equipment, laser safety, and biocompatibility, as well as software validation. These are not performance acceptance criteria for the intended use (tattoo and lesion removal) in the way you are asking.

Therefore, I cannot provide the detailed information requested in your prompt as it is not present in the provided text.

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