Evaluation of Safety and Efficacy of Morpheus8 Applicator for the Treatment of Focal Hyperhidrosis of the Axillae Using Radio Frequency

Inclusion Criteria: Subject is 18 years of age or older at the time of consent.

• Subject reports a quality-of-life rating of 3 or 4 on the Hyperhidrosis DiseaseSeverity Scale (HDSS).
• Subject has primary focal axillary hyperhidrosis evidenced by at least 6 months ofvisible, detectable, focal, exaggerated sweating without any apparent explanation andat least two of the following:
• Bilateral and relatively symmetric
• Impairs daily activities
• Frequency of at least one episode per week
• Age of onset less than 25 years old
• Positive family history
• Cessation of focal sweating during sleep
• Subject is willing and able to comply with protocol requirements and all study visits
• Willing to have de-identified images of the treated areas taken for possible use inpublications and presentations.
• Subject understands the study and has provided written informed consent

Exclusion Criteria: Subject has secondary hyperhidrosis due to medications, infections, malignancy orendocrinopathy.

• Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction andhormonal virilization.
• Severe concurrent conditions such as cardiac disorders epilepsy, uncontrolledhypertension, and liver or kidney diseases.
• Any active skin condition in the treatment area, such as sores, psoriasis, eczema andrash.
• Swollen axillary lymph nodes.
• History of skin disorders, keloids, abnormal wound healing, as well as very dry andfragile skin.
• Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or useof immunosuppressive medications.
• History of bleeding coagulopathies or use of anticoagulants in the last 10 days.
• Prior endoscopic thoracic sympathectomy, liposuction or other surgery forhyperhidrosis in the treated area. Injection of botulinum toxin in the treated areawithin one year
• Use of Isotretinoin (Accutane®) within 6 months prior to study
• Oral anticholinergic medication use (e.g., Robinul) or cholinomimetic medication usewithin the last 4 weeks or planned use during the study's follow up phase.
• Currently participating in or recently participated in another clinical trial (withinthe last 30 days).
• History of or current neurologic deficit in the treatment limb.
• Known resistance to or history of difficulty with local anesthesia (lidocaine withepinephrine).
• Current or history of cancer, including skin cancer, or premalignant moles.
• Injury in the treatment area or any other condition that, in the opinion of theinvestigator, might make treatment unsafe.
• Subject has a pacemaker, defibrillator or other electronic implant anywhere in thebody.
• Permanent implant in the treated area such as metal plates, screws and metal piercingor silicon.
• Females who are pregnant or nursing
• Female subjects of childbearing potential not willing to use an acceptable form ofcontraception for the duration of the study.