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The SONOCA Lipo is an instrument indicated for selected ultrasound dissection, liquefaction, emulsifying and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery, and Gynecological Surgery applications. It is also indicated for the liquefaction and aspiration of localized subcutaneous fatty tissue for aesthetic body contouring.

SONOCA Lipo™ is a modified version of the SONOCA 300 cleared by FDA under K992026 and can be used in two ways:

1. As an ultrasonic dissector / aspirator as in the SONOCA 300 to cut, irrigate, and suction at the surgical site and
2. As an alternative to conventional Lipectomy because it is a combination of a standard Lipectomy suction device and an Ultrasound assisted Lipectomy for the selective dissection of human fatty tissue.

The SONOCA Lipo™ can be trolley mounted or a desktop unit consisting of an ultrasonic generator, an infiltration pump and an aspiration pump. The nodular build of the electronic components allow the unit to function at a high capacity, totally free of electronic maintenance.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets specific acceptance criteria.

The documents are FDA 510(k) letters and summaries for the Soring GmbH Sonoca Lipo, an ultrasonic surgical instrument. They describe the device, its indications for use, and its substantial equivalence to predicate devices, but they do not contain any details regarding clinical or analytical performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert evaluations.

The "Performance Data" section in {5} only states that the device has been designed and tested to pass various voluntary safety and EMC standards (e.g., UL 2601-1, EN 60601-1, IEC 950). This refers to compliance with engineering and electrical safety standards, not an evaluation of its clinical efficacy or diagnostic performance against acceptance criteria.

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