Secret Micro-Needle Fractional RF System® for the Treatment of Facial Wrinkles

Subjects satisfying all inclusion and exclusion criteria will be enrolled in this trial.
After baseline evaluation, all subjects will undergo a series of 3 facial treatments with the
Secret Micro-Needle Fractional RF System® at 4 week intervals.

Blinded-investigator and subject self-assessments will be performed at Baseline and Days 28,
56, 146, and 180 to evaluate treatment efficacy for facial wrinkling. Of note, the
blinded-investigators will be blinded to treatment settings and technique, and number of
treatments. Safety will be evaluated by subject diaries, as well as investigator- and
subject-rated evaluations of adverse events at all follow-up visits. Mandatory standard 2D
digital photography, Canfield VISIA and VECTRA 3D digital photography will be performed at
baseline and at each office visit.

Inclusion Criteria:

1. Males or females in good general health who are greater than 22 years of age.

2. Subjects may be of Fitzpatrick Skin Types I through VI.

3. Subjects must desire improvement of facial skin texture and wrinkling.

4. Subjects must have at least a score of 2 on the Fitzpatrick Wrinkle Scale evaluating
the forehead, cheeks, and periorbital areas and Modified Fitzpatrick Wrinkle Scale
evaluating the nasolabial folds (Appendix A1 and A2).

5. Subjects must be willing to provide written informed consent, HIPAA authorization, and
photographic release.

6. Subjects must be willing to follow study instructions and complete all required
visits.

7. Negative urine pregnancy test results at the time of study entry (if applicable).

8. The subject is healthy as judged by medical history and investigator's assessment of
current health

9. Female subjects will be either of non-childbearing potential defined as:

1. Having no uterus. 2. No menses for at least 12 months. Or; (WOCBP) women of childbearing
potential must agree to use an effective method of birth control during the course of the
study, such as:

1. Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
(systemic birth control must have been started 30 days or more prior to enrolling)

2. Intrauterine coil

3. Bilateral tubal ligation

4. Barrier method used with an additional form of contraception (e.g., sponge, spermicide
or condom)

5. Abstinence (If practicing abstinence must agree to use barrier method described above
(4) if becomes sexually active).

6. Vasectomized partner (Must agree to use barrier method described above (4) if becomes
sexually active with non-vasectomized).

Exclusion Criteria:

1. A subject who has undergone treatment with any non-ablative laser, including IPL,
within the last 3 months and any ablative laser within the last 6 months.

2. A subject who has undergone any microneedling treatment within the last 3 months

3. A subject with a history of previous fat transfer, injectable calcium hydroxylapatite
or poly-l-lactic acid to the study area within the past 6 months.

4. A subject with a history of injection of hyaluronic acid dermal fillers in the study
area within the past six months.

5. Retinoid, hydroquinone, microdermabrasion, or chemical peel treatments to the face
within one month prior to study participation or during the study.

6. Current participation or participation within 30 days prior to the start of this study
in a drug or other investigational research studies.

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

8. Presence of scarring, sunburn, tattoos, open wounds or other skin condition in area to
be treated that would interfere with the assessments of this study.

9. Individuals who have current skin cancers or suspicious lesions in the treatment area
per Investigator.

10. Individuals who are nursing, pregnant, or planning to become pregnant during the
study.

11. Patients who have a history with keloid formation or hypertrophic scarring.

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

13. Subjects with deep dermal scarring or thick sebaceous skin of the treatment area.

14. History of impaired immune system, including but not limited to HIV, current
malignancy.

15. History of chronic drug or alcohol abuse.

16. Current smoker or history of smoking in the last one year.

17. Subjects with known bleeding disorder or is receiving medication that will likely
increase the risk of bleeding as the result of injection per investigator discretion.

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

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

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

21. History of using the following prescription medications:

1. Current use of psychiatric drugs that in the investigators opinion would impair
the subject from understanding the protocol requirements or understanding and
signing the informed consent.

2. Immunosuppressive medications.

22. Subjects with implantable cardiac devices, such as pacemakers or implantable
cardioverter-defibrillators.