Section 10: Forma Treatment Information
10.1 Indications for Use
The Forma Handpiece is intended for use in dermatologic procedures for noninvasive
treatment of mild to moderate facial wrinkles and rhytids. Hand pieces is indicated
for the temporary relief of minor muscle aches and pain, temporary relief of muscle
spasm, and temporary improvement of local blood circulation.
10.2 Contraindications
▪ Pacemaker or internal defibrillator, or any 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, silicone implants or an injected chemical substance, unless deep enough
in the periosteal plane.
▪ Intra-dermal or superficial sub-dermal areas that have been injected with
HA/collagen/fat injections or other augmentation methods with bio-material
during last 6 months.
▪ Current or history of skin cancer, or current condition of any other type of
cancer, or pre-malignant moles.
▪ Severe concurrent conditions, such as cardiac disorders, sensory disturbances,
epilepsy, uncontrolled hypertension, and liver or kidney diseases.
▪ Pregnancy and nursing.
▪ Impaired immune system due to immunosuppressive diseases such as AIDS and
HIV, autoimmune disorders or use of immunosuppressive medications.
▪ Patients with history of diseases stimulated by heat, such as recurrent Herpes
Simplex in the treatment area, may be treated only following a prophylactic
regimen.
▪ Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction
and hormonal virilization.
▪ Any active condition in the treatment area, such as sores, psoriasis, eczema, and
rash.
▪ History of skin disorders, keloids, abnormal wound healing, as well as very dry
and fragile skin.
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