This is an open-label, multi-center study. Subjects in this study will receive up to eight (8) treatments in 11±5 weeks (6-16 weeks) interval, with the PicoWayTM device using the 1064 nm/ 785±20 nm/ 532 nm handpiece according to the study protocol (tattoo colors). Subjects will return for one follow-up (FU) visit at the clinic at 8 weeks following the last treatment. Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic
This study is a prospective clinical study to demonstrate the safety and efficacy of the PicoWayTM device for tattoo removal. Up to a total of 60 healthy candidates who are seeking tattoo removal clearance treatment from participating investigators will be enrolled at up to 3 participating study sites. Subjects will receive up to eight (8) PicoWayTM treatments at 11±5 (6-16) week's intervals. Prior to each consecutive treatment, the investigator will decide, based on degree of clearance assessment, should the subject undergo additional treatment or to be forwarded to the 8 weeks Follow-Up visit with no more treatments. Topical anesthetic (ointment) or intradermal injected solution may be used prior to treatment. Each subject will be followed at one post treatment visit that will be conducted at: • Eight weeks post last treatment - 8wk FU.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
solid state laser capable of delivering energy at wavelengths of 1064 nm or 532 nm or wave length of 785±20 nm that was added to the system
Main Line Center for Laser Surgery
Ardmore, Pennsylvania, United States
Global percentage of tattoo clearance
Global percentage of tattoo clearance as assessed by blinded evaluators based on comparing pre and post treatment photos.
Time frame: 8 weeks post final treatment
Rate of tattoo clearance
Average number of treatments determined to achieve 50 and 75 percent clearance
Time frame: 8 weeks post final treatment
Adverse event reporting
Based on rate and severity of treatments with the PicoWay laser treatment
Time frame: Through study completion, average of 1 year
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