Description
Inclusion Criteria:
- 1. Male or female subjects aged 18-85 years
- 2. Fitzpatrick skin type I-VI
- 3. Has visible skin laxity in the treatment region or has a scar
- 4. Post-menopausal or 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 for the duration of the study (Applicable to female subjects only)
- 5. Willing to have digital imaging and measurements taken of the treatment area and agree to use for presentation, educational or marketing purposes
- 6. Subject must be able to read, understand and sign Informed Consent Form in English
- 7. Must be willing to adhere to the treatment and follow-up schedule and post-treatment care instructions
Exclusion Criteria:
- 1. Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
- 2. Any type of prior cosmetic treatment to the target area at physicians' discretion
- 3. History of malignant tumors in the target area.
- 4. Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, large moles.
- 5. Pregnant and/or breastfeeding (Applicable to females only)
- 6. Having an infection, dermatitis or a rash in the treatment area.
- 7. Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, e.g., uncontrolled hypertension or pertinent neurological disorders.
- 8. Suffering from coagulation disorders or taking prescription anticoagulation medications.
- 9. History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
- 10. History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
- 11. History of vitiligo, eczema, or psoriasis.
- 12. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
- 13. History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
- 14. Current smoker or history of smoking within 6 months of study participation.
- 15. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
Ages Eligible for Study:
18 Years to 85 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Yes