Clinical Evaluation of the Picosure Laser for the Treatment of Unwanted Tattoos

Inclusion criteria

• Is a healthy non-smoking (must have quit 6 months prior) male or female between 18 and 65 years old.
• Is willing to consent to participate in the study.
• Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits
• Has unwanted non-cosmetic tattoo containing red ink, that has not previously been treated, and wishes to undergo laser treatment

Exclusion criteria

• The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
• The subject is hypersensitive to light exposure OR takes photo sensitized medication.
• The subject has active or localized systemic infections.
• The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).
• The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
• The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
• The subject has used Accutane within 6 months prior to enrollment.
• The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
• The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
• The subject has a history of keloids.
• The subject has evidence of compromised wound healing.
• The subject has a history of basal cell carcinoma, squamous cell carcinoma or melanoma.
• The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.