| Eligibility |
Inclusion Criteria:
1. Must be able to understand and provide written informed consent and release of health
information
2. Male or Female, 25 to 65 years of age (inclusive)
3. Fitzpatrick Skin Type I - VI (Appendix 4)
4. Has visible wrinkles or skin laxity in the treatment area
5. On the Fitzpatrick Classification Wrinkle Classification System subject has a
pre-treatment score of 4-9 (inclusive) (Appendix 5)
6. No use of tobacco products for at least 6 months and willing to refrain from use for
the duration of the study
7. Subject must agree to not undergo any other cosmetic procedure(s) area, or start
topical retinol products in the treatment area during the study period
8. Subject must be willing to adhere to the follow-up schedule and study instructions
9. Subject must be willing to adhere to the same diet and/or exercise routine throughout
the study, and agree to maintain the same weight throughout the study, within 10% of
baseline weight measurement
10. Willing to have digital photographs taken of the treatment area and agree to use of
photographs for presentations, educational, and/or marketing purposes
11. For female subjects: not pregnant or lactating and is either post-menopausal,
surgically sterilized, or using a medically acceptable form of birth control at least
3 months prior to enrollment and during the entire course of the study, and no plans
to become pregnant -
Exclusion Criteria:
1. Participation in a clinical trial of a drug or another device in the target area
within 3 months of study participation, or during the study.
2. Any type of prior cosmetic treatment to the target area within 12 months of study
participation e.g., radiofrequency, cryolipolysis, deoxycholate injection, or
light-based treatments
3. Prior injection of botulinum toxin, collagen, hyaluronic acid filler, or other dermal
filler, and medium-depth to deep chemical peels, to the treatment area within 6 months
of study participation
4. History of systemic steroid use within 3 months; history of topical steroid use in the
target area within 2 months
5. History of systemic retinoid (isotretinoin) and therapeutic dose of Vitamin A within 6
months of study participation
6. Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve
stimulator implant, cochlear implant or any other electronically, magnetically or
mechanically activated implant
7. Has metal implant(s) within the body that are local to the treatment area, such as
surgical clips, plates and screws (metal tooth fillings or crowns will not exclude
subject participation), or has , artificial heart valves or artificial joints
8. Clinically significant concurrent illness, such as diabetes mellitus, cardiovascular
disease, peripheral vascular disease or pertinent neurological disorders that in the
opinion of the Investigator will confound participation in the study
9. Diagnosed or documented immune system disorders
10. History of any disease or condition that could impair wound healing
11. History of diseases stimulated by heat, such as recurrent herpes zoster in the
treatment area, unless treatment is conducted following a prophylactic regimen
12. History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing
13. Infection, dermatitis, rash or other skin abnormality in the target area
14. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or
history of treatment in the target area within 3 months of study participation
15. Anticipated or planned need for surgery or hospitalization during the duration of the
study
16. Pregnant, nursing, or planning a pregnancy during the trial; or is a woman of child
bearing potential but is not willing to use an acceptable method of contraception as
determined by the Investigator
17. As per the Investigator's discretion, any physical or psychological condition which
might make it unsafe for the subject to participate in this study -
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