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The YandR System is intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Handpiece.

The YandR System, subject of this submission as well as the cleared systems of the Legend Pro RF Family of Systems (Pollogen Legend+ system (listed as Legend Pro); see K122200, K131758, K171359 and K173503) are computer-controlled RF devices connected to a treatment Handpiece/Applicators and disposable tips. The system is comprised of:

• System Console
• . VoluDerm Handpiece/Applicator and single-use sterile removable tips (present only in the Surgen, Legend Pro and YandR Systems)
  The YandR System with its VoluDerm Handpiece is a new model of the modified Legend Pro Family of RF Systems The YandR System as the cleared Pollogen Legend+ system can generate a 1MHz sinusoidal signal applied by the VoluDerm Handpiece and the same VoluDerm Tips with bi-polar electrode pins at up to 62 Joules/per pin. The proposed system relies on the same fundamental underlying technology of the cleared systems with some hardware and software modifications to meet the marketing requirements for a more compact and simple device (tabletop console instead of a floor-mounted, rolling console) with a modern interface and the support of only the VoluDerm Handpiece (removing the TriPollar Applicators), similarly to its predecessor, the Pollogen Ltd.'s Surgen U (K131758). Also, to simplify the system, the YandR system has a hand switch, integrated into the VoluDerm Handpiece (called the Handpiece Trigger), instead of a separated Footswitch.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to efficacy or clinical performance.

The document is a 510(k) summary for the YandR System, focusing on demonstrating substantial equivalence to a predicate device (Pollogen Legend+ system). It discusses hardware and software modifications and safety and performance testing for electrical, RF, electromagnetic compatibility, and software verification/validation. However, it does not include:

• A table of acceptance criteria and reported device performance related to a clinical outcome.
• Details about sample size, data provenance, ground truth establishment, or expert involvement for clinical performance evaluation.
• Any mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or standalone algorithm performance.

The "studies" mentioned (Risk analysis, Electrical, RF, EMC safety testing, Software verification/validation, System testing) are engineering and safety verification tests, not clinical performance studies demonstrating the device meets specific efficacy acceptance criteria.

The conclusion states that "Test results indicated that the YandR System performs in accordance with its requirements and specifications similarly to its predicate Pollogen Legend+ system...", but these "requirements and specifications" refer to technical performance and safety, not clinical efficacy metrics.

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