Subject Reported Pain; Conclusion; Description Of Procedure; Pre-Procedure - Ulthera Cellfina System System-Gebrauchsanweisung

Ulthera, Inc.

Subject Reported Pain

Using a 0-10 numerical rating scale (NRS), subjects were asked to rate and then describe any pain in the treatment
area at baseline, immediately post-procedure and at each of the follow-ups. The highest procedural pain levels were
recorded during anesthetic delivery and were consistent with similar cosmetic procedures.
On average, 71% of subjects rated pain ≤ 3/10 at 3 days, and over 95% rated pain ≤ 3/10 thereafter. The majority of
the experienced pain was described as "aching" and occurred only with touch or pressure. There was no pain
reported at the 1 year, 2 year, or 3 year follow-up.

Conclusion

All study endpoints were achieved. The pivotal study data demonstrates that the Cellfina
effective for the long term improvement in the appearance cellulite in the study population.

DESCRIPTION OF PROCEDURE

The ideal candidates for the Cellfina
on the buttocks and/or upper thighs. Recommendations, from the clinical experience and literature, for patient
selection and treatment are summarized below. Specific usage instructions are provided in the Directions for Use
section.

Pre-Procedure

Patients should be evaluated in a standing position with relaxed muscles, and the evident depressions assessed
for treatment. A light source in a downward position is helpful to visualize the depressions. If the patient is a
good candidate for the procedure, the following are recommended:

Patients should discontinue, if medically feasible, any drugs or dietary supplements that could prolong
bleeding at least 14 days prior to the procedure.

Prophylactic antibiotic therapy is recommended.

Review the patient's medical history for evidence of disease, condition, or drug use and compare to the
contraindications or which may compromise the results of the procedure.

Patient Marking and Photography


Patients should be photographed and marked in a standing position with relaxed muscles. A light
source in a downward position is helpful to visualize and mark the depressions to be treated.

Patients should be provided with standard, disposable undergarments which do not interfere with the
intended areas of treatment.

A baseline photograph of the intended treatment area(s) should be taken with tight control over position
and lighting. Note: Ulthera can provide assistance with recommended photography equipment and set-
up. Each photo should be labeled with a unique patient identifier and the date. It is recommended that
this information be placed in the field of view when taking the photos (i.e., label on the patient's small of
the back) with attention being paid to not covering, or being too near, the treatment area.

The areas for treatment should be marked using the same positioning and lighting as the photography.
A water-resistant surgical marking pen can be used to encircle or mark the intended areas of release. If
there are a large number of sites, incorporating a strategy for identifying priority and depth of release is
suggested. Areas to avoid or be more cautious about are listed in the Subcutaneous Tissue Release
Section below.

If possible, take a picture of the marked patient in the same position as the pre-procedure photo. A
printed copy of this picture can be used during the procedure for reference and record keeping of the
areas treated.
1007270IFU Rev D
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Cellfina System
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System are healthy patients who present with evident depressions of cellulite
User Manual
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System is both safe and
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