Ulthera System (UC-1 Control Unit PRIME Model 2.1)

The Ulthera System is a focused ultrasound device for non-invasive aesthetic skin treatment. It applies low-intensity, highly focused ultrasound energy to achieve temporary improvements in skin appearance, including eyebrow lifting, neck and submental tissue tightening, reduction of décolletté lines and wrinkles, and improvement of skin laxity on the abdomen and arms. The device includes an imaging mode using the DeepSEE transducer to visualize tissue up to 8 mm below the skin surface for proper treatment planning.

The subject device shares identical ultrasound signal energy, main components (console with touchscreen, handpiece, interchangeable transducers), and imaging mode with the predicates. Key differences are: wireless connectivity via USB Wi-Fi adapter (predicates have none), new SEE.PLAN.TREAT.® treatment planning mode (predicates have only Amplify mode), expanded color maps including Bone and Twilight modes (predicates use only monochromatic), six console connection ports versus two on predicates, and software version 2.1.6400 versus 2.1.2030/2036. These hardware and software differences do not affect clinical functionality or performance specifications.

Electrical safety and EMC compliance verified to IEC 60601-1 and IEC 60601-1-2. Usability testing conducted per IEC 62366-1 and FDA guidance on human factors. Software verification and validation per FDA guidance on device software functions using basic documentation level. Cybersecurity testing per FDA guidance on cybersecurity in medical devices.

The subject device maintains the same intended use, indications for use, and core operational principle (low-intensity focused ultrasound for aesthetic skin treatment) as both predicates. The subject device produces identical ultrasound energy and uses identical main system components and imaging functionality. Minor software and hardware differences—wireless connectivity, new treatment mode, additional color maps, and increased connection ports—have been verified and validated through testing but do not alter clinical functionality, performance specifications, or safety profile. The nonclinical testing demonstrates the device operates as intended and is as safe and effective as the predicates for the stated indications.