At 90 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:

1. - Very Much Improved
2. - Much Improved
3. - Improved
4. - No Change
5. - Worse "Any Improvement" includes participants assessed in categories 1-3

At 180 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:

1. - Very Much Improved
2. - Much Improved
3. - Improved
4. - No Change
5. - Worse "Any Improvement" includes participants assessed in categories 1-3

Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated on a PSQ whether they saw improvement in the areas treated, i.e., providing a Yes/No response, and how satisfied they were with their Ulthera treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment, comparing pre-treatment and 90 day post-treatment photos. Proportions of subjects reporting Improvement, and Very Satisfied and Satisfied are included.

Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated on a PSQ whether they saw improvement in the ares treated, i.e., providing a Yes/No response, and how satisfied they were with their Ulthera treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 180 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment, comparing pre-treatment and 180 day post-treatment photos. Proportions of subjects reporting Improvement, and Very Satisfied and Satisfied are included.

At baseline, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:

• Horizontal neck folds (Grades 0-6)
• Neck sagging (Grades 0-7);
• Texture (Female grades 0-5; male grades 0-7);
• Ptosis (Female grades 0-5; males grades 0-7).

At 90 days post-treatment, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:

• Horizontal neck folds (Grades 0-6)
• Neck sagging (Grades 0-7);
• Texture (Female grades 0-5; male grades 0-7);
• Ptosis (Female grades 0-5; males grades 0-7).

At 180 days post-treatment, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:

• Horizontal neck folds (Grades 0-6)
• Neck sagging (Grades 0-7);
• Texture (Female grades 0-5; male grades 0-7);
• Ptosis (Female grades 0-5; males grades 0-7).

Dual depth treatment on the submental, submandibular and lower neck regions.

Total of all reporting groups

Skin Type I = White;very fair,red or blonde hair blue eyes;freckles;Always burns, never tans

Skin Type II = White, fair, red or blond hair; blue, hazel or green eyes;Usually burns, tans with difficulty

Skin Type III = Cream white; fair with any eye or hair color (common); Sometimes mild burn, gradually tans

Skin Type IV = Brown; typical Mediterranean Caucasian skin; Rarely burns, tans with ease

Skin Type V = Dark Brown; mid-eastern skin types; Very rarely burns, tans easily

Skin Type VI = Black; Never burns, tans very easily

Participants that received dual depth Ultherapy® treatment on the lower face, submental, submandibular, and lower neck regions.

Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) of 25 participants completed the 90-day study visit; 1 participant was lost-to-follow-up

Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.

At 60 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:

1. - Very Much Improved
2. - Much Improved
3. - Improved
4. - No Change
5. - Worse "Any Improvement" includes participants assessed in categories 1-3

At 60 days post-treatment, the PI and subject completed a Global Aesthetic Improvement Scale (PGAIS and SGAIS, respectively)for comparison to pre-treatment.

At 90 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:

1. - Very Much Improved
2. - Much Improved
3. - Improved
4. - No Change
5. - Worse "Any Improvement" includes participants assessed in categories 1-3

At 90 days post-treatment, the PI and subject completed a Global Aesthetic Improvement Scale (PGAIS and SGAIS, respectively)for comparison to pre-treatment.

Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis.

A data set of 42 of the 61 participants were re-analyzed. Data were removed for 19 participants whose pre-treatment and/or post-treatment photos were of poor photo quality, i.e., poor lighting, poor focus, poor positioning, creating the potential for biasing the masked assessment results.

Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 0 representing no pain and 10 representing the worst pain possible.

At 180 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:

1. - Very Much Improved
2. - Much Improved
3. - Improved
4. - No Change
5. - Worse "Any Improvement" includes participants assessed in categories 1-3

At 180 days post-treatment, the PI and subject completed a Global Aesthetic Improvement Scale (PGAIS and SGAIS, respectively)for comparison to pre-treatment.

Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated on a PSQ whether they saw improvement in the areas treated, i.e., providing a Yes/No response, and how satisfied they were with their Ulthera treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment, comparing pre-treatment and 90 day post-treatment photos. Proportions of subjects reporting Improvement, and Very Satisfied and Satisfied are included.

Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated on a PSQ whether they saw improvement in the ares treated, i.e., providing a Yes/No response, and how satisfied they were with their Ulthera treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 180 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment, comparing pre-treatment and 180 day post-treatment photos. Proportions of subjects reporting Improvement, and Very Satisfied and Satisfied are included.

At baseline, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:

• Horizontal neck folds (Grades 0-6)
• Neck sagging (Grades 0-7);
• Texture (Female grades 0-5; male grades 0-7);
• Ptosis (Female grades 0-5; males grades 0-7).

At 90 days post-treatment, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:

• Horizontal neck folds (Grades 0-6)
• Neck sagging (Grades 0-7);
• Texture (Female grades 0-5; male grades 0-7);
• Ptosis (Female grades 0-5; males grades 0-7).

At 180 days post-treatment, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:

• Horizontal neck folds (Grades 0-6)
• Neck sagging (Grades 0-7);
• Texture (Female grades 0-5; male grades 0-7);
• Ptosis (Female grades 0-5; males grades 0-7).

Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.

Dual depth treatment on the submental, submandibular and lower neck regions.