Laser Treatment of Tattoos With Pico Laser

The Investigational device is a dual wavelength laser system developed for treatment of pigmented lesions and for tattoo removal. The base unit is a GentleMax Pro laser system modified to emit light at wavelengths of 532 and 1064 nm and deliver pulse energy up to 400mJ, and pulse duration of 700 ps.

A multicenter study.

Inclusion criteria

• Has Fitzpatrick skin type I-IV
• Has unwanted non-cosmetic tattoo(s) and wishes to undergo laser treatments to remove them
• 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

Exclusion criteria

• Is hypersensitive to light exposure
• Has an active sun tan
• Has Fitzpatrick skin type V or VI
• Has active localized or systemic infection
• Is taking medication(s) for which sunlight is a contraindication
• Has a history of squamous cell carcinoma or melanoma
• Has a history of keloid scarring
• Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
• Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications
• Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period
• Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine