A Study of a Novel Multi-Wavelength Laser for Tattoo Removal

A single-center prospective, open-label, uncontrolled pilot study to evaluate the safety and
efficacy of an investigational version of the Cutera enlightenTM laser that offers multiple
wavelengths for tattoo removal.

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.

- 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.

- 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 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.