Tattoo; Pigmentation Clinical Trial
Official title:
Clinical Study to Evaluate the Performance of the PicoWayTM 1064 nm/ 785 nm/ 532nm Picosecond Laser for Tattoo Removal
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.
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