Section 9: Fractora Treatment Information
9.1 Fractional Skin Resurfacing
The Fractora Handpiece is designed for delivering RF energy to the skin surface in a
fractional manner with the energy applied to <10% of the total coverage area. The
energy is delivered to the skin through bipolar arrays of pins and results in localized
heating and ablation of the skin that is in direct contact with the pins. Ablation of the
skin promotes skin resurfacing while untreated skin between the pins promotes
faster healing of the tissue. There is also the contribution of non-ablative, non-
coagulating dermal matrix heating that occurs in the skin that is not subject to
fractional ablation.
9.2 Indications for Use
Fractora Handpiece with 60 pin tip is designed for use in dermatological procedures
requiring ablation and resurfacing of the skin.
Fractora Handpiece with 24 pin tip is intended for use in Dermatologic and General
Surgical procedures for Electrocoagulation and Hemostasis. At higher energy levels
greater than 62, use of the applicator is limited to Skin Types I-IV.
9.3 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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