| Eligibility |
Inclusion Criteria:
- Female or Male, 18 to 65 years of age (inclusive).
- Fitzpatrick Skin Type I - VI.
- Target tattoo contains single or multi-color ink, and must include blue and/or green
ink.
- Target tattoos must be older than 1 year.
- Target treatment area not to exceed 12 square inches.
- 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.
- Wiling to cover tattoos with a bandage or clothing; and/or have very limited sun
exposure and use an approved sunscreen of SPF 50 or higher on the treated area
starting 2 to 4 weeks before the treatment and/or every day for the duration of the
study, including the follow-up period.
- Willing to have digital photographs taken of the treatment area and agree to use of
photographs for presentation, educational or marketing purposes.
- Agree to not undergo any other procedure(s) for tattoo removal during the study (as
applicable).
- 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, and no plans to become pregnant for the duration of the study.
Exclusion Criteria:
- Participation in a clinical trial of a drug or another device in the target area
during the study.
- Target tattoo contains only black ink.
- History of allergic reaction to pigments following tattooing.
- History of allergy to local anesthetics.
- History of allergy to topical antibiotics.
- History of malignant tumors in the target area.
- Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large
moles.
- 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.
- History of immunosuppression/immune deficiency disorders or currently using
immunosuppressive medications per investigator's discretion.
- History of vitiligo, eczema, or psoriasis.
- History of connective tissue disease, such as 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, as applicable, within 6 months of
study participation.
- Anytime in life, having 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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