Study To Evaluate The Safety And Efficacy Of The MyEllevate® Procedure

Prospective Clinical Study To Evaluate The Safety And Efficacy Of The MyEllevate® Procedure

The intended purpose of the MyEllevate® procedure used in this study is to assess the safety and efficacy of the procedure for soft tissue approximation and elevation of sub dermis and underlying muscle of the submentum & jawline.

Subjects are to be enrolled in this clinical study if they are a healthy male or female between the age of 18 - 65. Up to 10 subjects will be enrolled at 2 study centers. All subjects will attend a screening/pre-procedure visit which may be performed on the same day as the procedure visit but no more than 30 days prior to their procedure.

Inclusion Criteria:

• A healthy male or female between the age of 18 - 65.
• Must have any or all the following: visible platysma bands, glands and/or sagging in the submentum, jawline and/or neck.
• Reads and understands English.
• Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
• Understands and accepts the obligation and is logistically able to be present for all visits.
• Is willing to comply with all requirements of the study and sign the informed consent document.

Exclusion Criteria:

Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.

• Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months (or at the discretion of the Investigator) prior to entering this study.
• Have received any treatments or procedures (including injectables such as Botox or fillers) in the area to be treated at least 4 months prior to treatment.
• Take antiplatelets, anticoagulants, thrombolytics, or anti-inflammatories.
• Have an active localized or systemic infection.
• Have an open wound in area being treated.
• Have a significant systemic illness or an illness localized in area being treated.
• Have had recent surgeries or problems in the treatment area (e.g. neck fracture, neck sprain, pinched nerve, spondylosis, arthritis in the neck).
• Have a history of thrombophlebitis.
• Have a history of heart failure or kidney disease.
• Have a history of allergic reaction or intolerance to the anesthesia used during the procedure.
• Have a history of poor wound healing.
• Have a history of poor circulation.
• Have a systemic autoimmune disease known to impair wound healing.
• Have a history of keloid formation.
• Currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within the area to be treated 6 months (or at the discretion of the Investigator) prior to entering this study.
• Has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.