Section 6: DiolazeXL Treatment Information
DiolazeXL hair removal treatment is based on principles of selective
photothermolisys. The light penetrates into the skin and is selectively absorbed by
melanin of the hair shaft. The absorbed energy is converted into heat, coagulating
the hair follicle. Multiple treatments are required for best results. White hairs are
resistant to the treatment due to scares pigmentation in the hair shaft. DiolazeXL
810nm is a universal hair removal for all skin types.
6.1 Instructions for Use
The Optimas System with the DiolazeXL 810nm Handpiece is intended for hair
removal and permanent hair reduction defined as the stable, long-term reduction in
hair counts at 6, 9, or 12 months following a treatment regime.
6.2 Contraindications
▪ Hair removal by lasers or intense pulse light sources can cause increased hair
growth in some individuals. Based upon currently available data, the highest risk
groups for this response are females of Mediterranean, Middle Eastern, and
South Asian heritage treated on the face and neck.
▪ 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,
polycystic ovary 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.
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