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as IEC 62304, IEC 62366, ISO 13485, ISO14971, and ISO 10993.
The labels on the device and on the packaging serve as evidence of conformity to these requirements.
Labeling provided on the unit and the handpieces are important for safety and regulatory purposes and
should not be removed, obscured, or altered. The label on the main unit can be found on the back panel
adjacent to the power cord inlet. Labeling on the handpieces are on the body of each handpiece. Access to
and use of the Ultimate Contour should be limited to clinicians and technicians who are properly licensed
and trained to use this device, consistent with national and state regulations. When not in use, the unit
should be secured to prevent unauthorized access.
2.5 Performance and Expectations
To demonstrate the stated performance of the ultrasound portion of this device, a clinical study was
conducted to identify the effectiveness of this device to reduce the waist circumference of patients using
the ultrasound portion. This study evaluated a total of 42 individuals who were treated for 30 minutes at an
intensity level of 4 during each treatment session. There were a total of 3 treatment sessions with 5-7 days
interval between sessions. The results show that on average a total waist reduction for the entire regimen
was 2.0 inches. The study included a 4-week follow-up where the overall waist reduction was still holding
at 2.0 inches on average.
This information is provided as a guide to the clinician when discussing expectations and potential results
with the patient.
3 - DEVICE DESCRIPTION
3.1 Kit Contents
When first opening the package, please review the contents to ensure you have received everything
needed to utilize the Ultimate Contour system:
• Ultimate Contour Unit
• 1) Radio Frequency Handpiece
• 1) Ultrasound Handpiece
• Power Cord
3.2 Device Features
Take a moment to familiarize yourself with the design and features of the Ultimate Contour System.
Ultimate Contour
Model: 005-00036
Rear Connection Panel
Power Switch
Power Cord
Connection
Safety Stop
Handpiece Connection
Summary of Contents for Ultimate Contour
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