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The Portrait® PSR³ is indicated for treatment of the following dermatological conditions:

• Treatment of wrinkles and rhytides
• Superficial skin lesions
• Actinic Keratosis
• Viral Papillomata
• Seborrhoeic Keratosis

The Portrait® PSR³ is an electro-surgical device for use in dermatological applications. UHF energy from the generator converts Nitrogen gas into plasma within the handpiece. The plasma emerges from the nozzle at the distal end of the handpiece and is directed onto the skin to be treated. Rapid heating of the skin occurs as the excited gas gives up energy to the skin. Through the combination within the handpiece of precisely controlled energy and Nittrogen gas, individual plasma pulses are produced that will give predictable tissue effects.

The provided 510(k) summary for the Rhytec, Inc. Portrait® PSR3 indicates that no new performance data or clinical studies were required or performed for this specific submission (K071786).

The statement "The device modifications did not raise new questions of safety or efficacy, no performance data is required" directly addresses this. This implies that the device is considered substantially equivalent to a previously cleared predicate device (K060948 - Portrait® PSR3), and therefore, the acceptance criteria and supporting studies would have been established during the clearance of that predicate device.

Therefore, it is not possible to provide the requested information based solely on the provided document for this specific 510(k) submission.

If information about the acceptance criteria and studies were available, it would have been from the original 510(k) submission for the Portrait® PSR3 (K060948).

However, based on the principle that the current device is substantially equivalent to a predicate, we can infer that the predicate device likely met certain performance criteria for the indicated dermatological conditions.

Without access to the K060948 submission, I cannot populate the table or answer the specific questions comprehensively. The provided document explicitly states that for this 510(k) (K071786), no new performance data was required.

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