| Eligibility |
Inclusion Criteria:
- Female or Male, 18 to 65 years of age (inclusive).
- Fitzpatrick Skin Type I - VI (Appendix 3).
- Subject has black or dark brown unwanted hair.
- Subject must be able to read, understand and sign the Informed Consent Form.
- Must be willing and able to adhere to the treatment and follow-up schedule and
post-treatment care instructions.
- Willing to refrain from shaving the treatment area for 5 days prior to each study
visit.
- Willing to have digital photographs taken of the treatment area and agree to use of
photographs for presentation, educational or marketing purposes.
- Must agree not to use hair removal products, such as topical chemical depilatories, or
undergo any other hair removal procedure during the study, such as other laser and
light therapies or waxing.
- Willing to refrain from excess sun exposure and willing to wear sunscreen on the
treatment area during the study (including the follow-up period).
- Be in good health, as determined by the Investigator.
- Post-menopausal or surgically sterilized, or using a medically acceptable form of
birth control at least 3 months prior to enrollment and during the entire course of
the study
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.
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