A single-center prospective, open-label, uncontrolled study in 10 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo which contains all black ink.
This is a single-center prospective, open-label, uncontrolled study in 10 male or female subjects, age 18 to 65 years, who desire laser removal of a tattoo which contains all black ink. Subjects will receive up to 5 laser treatments, spaced 4 to 6 weeks apart, and will be followed at 3 months post-final treatment. Number of laser treatments required shall be based upon tattoo response to laser irradiation. The Investigator will terminate laser treatments upon 100% clearance of tattoo or after 5 treatment sessions, or in the event of an adverse effect which requires cessation of laser treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Cutera enlighten dual wavelength 532nm KTP/1064nm Nd:YAG laser
ICLS Dermatology and Plastic Surgery
Oakville, Ontario, Canada
Physician's Global Assessment of improvement post-final treatment
Assessment of tattoo clearance by independent blinded reviewers
Time frame: 3 months
Subject's Global Assessment of improvement post-final treatment
Assessment of tattoo clearance by subject
Time frame: 3 months
Subject Satisfaction post-final treatment
Assessment of subject satisfaction with treatment results.
Time frame: 3 months
Incidence and severity of adverse device effects
Assessment of ADEs immediately following each laser treatment and at the final follow-up visit.
Time frame: Day 0, 4 wks, 8wks, 12 wks, 16 wks, 28 wks
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