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InMode Optimas - Section 7: Vasculaze Treatment Information; Vasculaze Indications for Use; Vasculaze Contraindications

InMode Optimas
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Section 7: Vasculaze Treatment Information
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Section 7: Vasculaze Treatment Information
Vasculaze is a diode laser at 1064nm wavelength that is intended to treat
predominantly blue reticular leg veins at a diameter of 1-4mm and depth of up to
5mm, including perforating veins. Due to the low absorption of 1064nm in
hemoglobin, 500-600nm lasers or IPL are a better choice to treat red telangiectasia
less than 1mm in diameter.
7.1 Indications for Use
The InMode System with the Vasculaze Handpiece is intended for the coagulation
and hemostasis of benign vascular lesions such as, but not limited to, port wine
stains, hemangiomas, warts, telangiectasias, rosacea, venous lake, leg veins, spider
veins, and poikiloderma of Civatte.
7.2 Contraindications
Saphenous insufficiency.
Current or history of skin cancer, or current condition of any other type of
cancer, or pre-malignant moles.
Pregnancy and nursing.
Impaired immune system due to immunosuppressive diseases such as AIDS and
HIV 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, 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.
Severe concurrent conditions, such as cardiac disorders, sensory disturbances.
Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
Known skin photosensitivity or using drugs increasing skin photosensitivity.
Diseases that may be stimulated by light, such as epilepsy, lupus and urticaria.

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