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LOTUS Enhanced Shears are indicated for soft tissue surgical incisions when bleeding control and minimal injury are important. They may be used as an adjunct to or substitute for electrosurgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint). The Lotus Series 5 is indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. It may be used as an adjunct to or substitute for electrosurgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint)

LOTUS Series 4 Enhanced Shears: The LOTUS Series 4 Enhanced Shears consist of a reusable Transducer and a Single use Handpiece and are designed to use torsional ultrasound in the 35.4-36.6kHz range to cut and coagulate soft tissue during laparoscopic, open or bariatric surgery. The 2 types of LOTUS Series 4 Enhanced Shears subject to this application are the ES4-200CT transducer (with DS4-200CD Handpiece) that is designed for use in open surgery and the ES4-500CT transducer (with DS4-500CD Handpiece) that is designed for bariatric surgery. The new LOTUS Series 4 Enhanced Shears transducers have a similar waveguide and blade form to that of the ES4-400CT that was previously cleared as part of the Lotus Series 4 Ultrasonic Surgical System and Accessories (K151101). The LOTUS Series 4 Enhanced shears use an identical transducer stack and casing and the same LG4 generator cleared as part of K151101. The Handpieces are identical in function as those cleared as part of K151101. They are identical to the DS4-200SD and DS4-500SD except that they use the same curved jaw as the DS4-400CD. All of these devices are described in detail in K151101. All Transducers are reusable up to 50 times and the Handpieces are single use and provided sterile. LOTUS Series 5: The LOTUS Series 5 is a modification to the Lotus Series 4 Ultrasonic Surgical System and Accessories. LOTUS Series 5 consists of new Transducers and Handpieces but are driven by the same generator as in the predicate - the LG4. The Transducers and Handpieces offer the improved feature of 360° rotation, whereas the predicate has rotation limited to 240°. To facilitate this feature, it has been necessary to redesign the transducer so that it sits axially in the plane of the waveguide. It still uses torsional ultrasound in the 35.4-36.6kHz range at the waveguide blade to perform its surgical function. The output at the waveguide blade is substantially equivalent to that of the predicate. The Handpieces of LOTUS Series 5 have had the area where the transducer fits to the Handpiece altered to allow for the 360° rotation, but the outer appearance of the Handpieces remains unchanged from the predicate. All Transducers are reusable up to 50 times and the Handpieces are single use and provided sterile.