A Prospective Multi-Center Study of a Novel Dual-Wavelength Laser for Hair Removal

Exclusion Criteria

• •Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
• •Had any type of professional hair removal procedure, such as laser, light-based, RF or electrolysis, in the treatment area within 12 months of study participation.
• •Had other epilation treatment, such as waxing or mechanical epilator, in the treatment area within 6 months of study participation.
• •Subject shows signs of actinic bronzing or recent tanning in the treatment area, and unable/unlikely to refrain from tanning during the study
• •History of malignant tumors in the target area.
• •Pregnant and/or breastfeeding.
• •Having an infection, dermatitis or a rash in the treatment area.
• •Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
• •Suffering from coagulation disorders or taking prescription anticoagulation medications.
• •History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
• •Currently using immunosuppressive medications or history of immunosuppression/immune deficiency disorder, such as psoriasis, eczema, vitiligo, systemic lupus erythematosus or scleroderma.
• •History of seizure disorders due to light.
• •Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
• •History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen
• •History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
• •History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
• •Systemic use of corticosteroid or isotretinoin within 6 months of study participation.
• •Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
• •Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
• •Current smoker or history of smoking within 6 months of study participation.
• •As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.