Eligibility Details:
Inclusion Criteria:
1. Subject seeking surgical correction of abdominal tissue laxity with an abdominoplasty
within the subsequent 1-12 months.
2. Subject abdominal skin must be of appropriate quality to allow for proper study
treatment, as judged by the Investigator.
3. The subject must be willing to have punch biopsy specimens obtained from all treated
areas following treatment.
4. The Subject must sign a statement of informed consent to the Investigator and Sponsor.
Exclusion Criteria:
1. The subject is less than 18 or greater than 75 years of age.
2. Subject with excessive superficial skin laxity and/or striae of the abdomen, which
would prevent proper study treatment.
3. A subject that is unwilling to have punch biopsy specimens obtained from treated
areas.
4. Subject with a history of allergy to lidocaine or epinephrine.
5. Known history of keloids or bleeding/coagulation disorder.
6. Presence of surgical or non-surgical scars in the area to be treated.
7. Active inflammatory or infectious process or any other active or serious skin disease
in the area to be treated.
8. Planned surgical procedures with incisions and suturing in the area to be treated
during the course of the study.
9. Subjects who have had (or plan to have during the course of the study) an abdominal
skin treatment with any exclusionary treatments, medications, and/ or devices.
10. Subjects who have used oral isotretinoin or other oral retinoids during the study in
the prior 12 months or planning to be on them during the course of the study.
11. Subjects receiving antiplatelet, anticoagulant, or non-steroidal anti-inflammatory
agents within 2 weeks of treatment, or planning to receive during the course of the
study; in whom, in the Investigator's opinion, administration of radiofrequency
treatment may cause procedure-related complications.
12. Women who are pregnant, nursing or intend to become pregnant over the duration of the
study, or women who are of childbearing potential not protected by an effective
contraceptive method of birth control. Pregnancy status should be checked by urine
testing at baseline (Day 0).
13. Subjects who are unwilling or unable to give written consent to participate in the
study or unable to comply with the requirements of the clinical trial protocol.
14. Subjects who have received an experimental drug or device within the previous 3 months
prior to enrollment.
15. Subjects who are known as alcohol or drug abusers.
16. Subjects who are suffering from any physical or psychological condition, or are under
treatment for any such condition which, in the opinion of the Investigator, may
constitute an unwarranted risk or which may affect the subjects' compliance or
adherence to study procedures.