(136 days)
The LySonix Suction Lipoplasty System is intended for use in aesthetic body contouring.
The LySonix Suction Lipoplasty System consists of an Aspiration Pump, Aspiration Cannulas, Sterile Tubing Set, Microbial Filter, Collection Canisters, and Canister Liners.
The provided text is a 510(k) summary for the LySonix Suction Lipoplasty System, indicating FDA clearance based on substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance, device description, and indications for use, without detailing specific performance metrics, clinical study designs, or acceptance criteria.
§ 878.5040 Suction lipoplasty system.
(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.