Eligibility Details:
Inclusion Criteria:
1. Female or Male, 18 to 65 years of age (inclusive).
2. Fitzpatrick Skin Type I - VI (Appendix 3).
3. Target tattoo contains single or multi-color ink.
4. Subject must be able to read, understand and sign the Informed Consent Form.
5. Must be willing and able to adhere to the treatment and follow-up schedule and
post-treatment care instructions.
6. 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.
7. Willing to have digital photographs taken of the treatment area and agree to use of
photographs for presentation, educational or marketing purposes.
8. Agree to not undergo any other procedure(s) for tattoo removal during the study (as
applicable).
9. 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.
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Exclusion Criteria:
1. Participation in a clinical trial of a drug or another device in the target area
during the study..
2. Target tattoo contains only black ink.
3. History of allergic reaction to pigments following tattooing..
4. History of allergy to local anesthetics.
5. History of allergy to topical antibiotics.
6. History of malignant tumors in the target area.
7. Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large
moles.
8. Pregnant and/or breastfeeding.
9. Having an infection, dermatitis or a rash in the treatment area.
10. Significant concurrent illness, such as diabetes mellitus or cardiovascular disease,
e.g., uncontrolled hypertension.
11. Suffering from coagulation disorders or taking prescription anticoagulation
medications.
12. History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
13. History of immunosuppression/immune deficiency disorders or currently using
immunosuppressive medications.
14. History of vitiligo, eczema, or psoriasis.
15. History of connective tissue disease, such as systemic lupus erythematosus or
scleroderma.
16. History of seizure disorders due to light.
17. Any use of medication that is known to increase sensitivity to light according to
Investigator's discretion.
18. 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.
19. History of radiation to the treatment area or undergoing systemic chemotherapy for the
treatment of cancer.
20. History of pigmentary disorders, particularly tendency for hyper- or
hypo-pigmentation.
21. Systemic use of corticosteroid or isotretinoin within 6 months of study participation.
22. Anytime in life, having have used gold therapy (gold salts) for disorders such as
rheumatologic disease or lupus.
23. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning
during the study.
24. Current smoker or history of smoking within 6 months of study participation.
25. 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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common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
