Comparison Study of Picosecond and Nanosecond Pulse Durations Using a Q-switched Nd:YAG Laser for Tattoo Removal

Inclusion Criteria

• Females or Males, 18 to 55 years of age (inclusive).
• Fitzpatrick Skin Type I - VI.
• Tattoos containing black/blue ink alone or in combination with other colors. No tribal, scarred, high-ink density, or highly colorful tattoos.
• Target tattoos older than 1 year.
• 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 use hydroquinone approximately 4 weeks pre-treatment and post-treatment if required by Investigator.
• Willingness to have digital photographs taken of the treated area.
• Agree not to undergo any other procedure(s) for the tattoo removal during the study.
• 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 study of another device or drug within 6 months prior to enrollment or during the study.
• History of allergic reaction to pigments following tattooing.
• Presence of double tattoo in the treatment area or presence of tribal, scarred, high-ink density, or highly colorful single tattoos.
• 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.
• 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 the Investigator's discretion.
• History of herpes simplex and/or herpes zoster (shingles).
• 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 within 12 months of study participation.
• Use of oral isotretinoin within 12 months of study participation and topical use of isotretinoin within 6 months on the treated area.
• 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.