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

Exclusion Criteria

• •1. 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.
• •2. The subject is hypersensitive to light exposure OR takes photo sensitized medication.
• •3. The subject has active or localized systemic infections.
• •4. 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}).
• •5. The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
• •6. 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.
• •7. The subject has used Accutane within 6 months prior to enrollment.
• •8. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
• •9. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
• •10. The subject has a history of keloids.
• •11. The subject has evidence of compromised wound healing.
• •12. The subject has a history of basal cell carcinoma, squamous cell carcinoma or melanoma.
• •13. 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.