Section 6: Morpheus8 Body Treatment Information
6.1 Sub-dermal Fractional Treatment
The Morpheus8 Body Handpiece is designed for delivering RF energy to the
subdermal tissue in a fractional manner with the energy applied to <5% of the total
coverage area. The energy is delivered to the skin through bipolar arrays of coated
needles and results in localized heating and coagulation of the tissue that is in direct
contact with the needle tip. Coagulation of the skin promotes tissue remodeling
while untreated tissue between the pins promotes faster healing of the tissue. The
Morpheus8 Body Handpiece is versatile fractional technology to treat different body
areas. Depth settings above 4 mm are used for the treatment areas with
subcutaneous fat thickness of 1 cm or higher.
6.2 Indications for Use
The Morpheus8 Body applicator is intended for use in dermatologic and general
surgical procedures for electrocoagulation and hemostasis.
6.3 Contraindications
▪ Pacemaker or internal defibrillator, or other metallic or electronic implant
anywhere in the body. The Handpiece should be used at least 1cm away from
cochlear implants in the ear.
▪ Permanent implant in the treated area such as metal plates, screws and metal
piercing or silicon, unless deep enough in the periosteal plane.
▪ Intra-dermal or superficial sub-dermal areas injected with
Botox®/HA/collagen/fat injections or other augmentation methods with bio-
material, before the product has been dissipated (up to 6 months), except Botox
after binding to the facial muscles (3-7 days). It is possible to treat sooner over
injectable products placed in the deep, periosteal plane, as soon as the area has
healed (1-3 weeks).
▪ Current or history of skin cancer, or any other type of cancer, or pre-malignant
moles.
▪ Pregnancy and nursing.
▪ Severe concurrent conditions, such as cardiac disorders or sensory disturbances.
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