Peri-orbital and Peri-oral Wrinkle Reduction Trial

Inclusion Criteria:

- Male or female, age 30 to 75 years.

- Subject in good health.

- BMI<25

- Fitzpatrick wrinkle score of 3-7 in the peri-orbital and peri-oral areas.

- Moderate skin laxity in the peri-orbital area contributing to rhytids as assessed by
the investigator.

- Understands and accepts the obligation not to undergo any other procedures, including
neurotoxin and filler treatments, on the face through the follow-up period.

- Willingness to refrain from use of aspirin, Ibuprofen, Naproxen or any other NSAID,
and Vitamin E in the 2 weeks prior to each study treatment.

- Willingness and ability to continue with their current daily skin care routine, with
the exception of any use of products containing glycolic acid, for the duration of the
study.

- Willingness and ability to comply with protocol requirements, including returning for
follow-up visits and abstaining from exclusionary procedures for the duration of the
study.

- Subjects of childbearing potential must have a negative urine pregnancy test result
and must not be lactating at the Screening Visit and be willing and able to use an
acceptable method of birth control during the study.

- Absence of physical or psychological conditions unacceptable to the investigator.

- Willingness and ability to provide written consent for study-required photography and
adherence to photography procedures (i.e., removal of jewelry and makeup).

- Willingness and ability to provide written informed consent and HIPAA authorization
prior to performance of any study-related procedure.

Exclusion Criteria:

- Presence of an active systemic or local skin disease that may affect wound healing.

- BMI equal to or greater than 25

- Severe solar elastosis.

- Excessive subcutaneous fat in the area(s) to be treated.

- Mild or severe skin laxity on the area(s) to be treated.

- Significant scarring in the area(s) to be treated.

- Open wounds or lesions in the area(s) to be treated.

- Severe or cystic acne on the area(s) to be treated.

- Active implantables (e.g., pacemakers or defibrillators) or metallic implants in the
treatment area.

- Inability to understand the protocol or to give informed consent.

- Microdermabrasion, or prescription level glycolic acid treatment to the treatment
area(s) within 4 weeks prior to study participation or during the study.

- Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick
sebaceous skin in the area(s) to be treated.

- History of chronic drug or alcohol abuse.

- History of autoimmune disease.

- History of Bell's Palsy or epilepsy.

- History of diabetes.

- Has a known allergy, or a known history of sensitivity, to lidocaine, tetracaine,
para-aminobenzoic acid (PABA).

- Concomitant therapy that, in the investigator's opinion, would interfere with the
evaluation of the safety or efficacy of the study device.

- Subjects who anticipate the need for surgery or overnight hospitalization during the
study.

- Subjects who, in the investigator's opinion, have a history of poor cooperation,
noncompliance with medical treatment, or unreliability.

- Concurrent enrollment in any study involving the use of investigational devices or
drugs.

- Current smoker or history of smoking in the last five years.

- History of the following cosmetic treatments in the area(s) to be treated:

1. Skin tightening procedure within the past year;

2. Injectable fillers of any type within the past 12 or 24 months, depending on
type;

3. Neurotoxins within the past six months;

4. Ablative resurfacing laser treatment;

5. Nonablative, rejuvenative laser or light treatment within the past six months;

6. Surgical dermabrasion or deep facial peels;

7. Facelift, blepharoplasty, or browlift within the past 2 years; or

8. Any history of contour threads.

- History of using the following prescription medications:

1. Accutane or other systemic retinoids within the past six months;

2. Topical Retinoids within the past four weeks;

3. Antiplatelet agents/Anticoagulants;

4. Psychiatric drugs that in the investigators opinion would impair the subject from
understanding the protocol requirements or understanding and signing the informed
consent.