Picosecond Laser for Ttreatment of Benign Pigmented Lesions

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 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.

Inclusion Criteria:

1. Has Fitzpatrick skin type I-VI

2. Has unwanted benign pigmented lesions including but not limited to solar lentigines,
freckles, café au lait, melasma, New of Ota, Nevus of Ito, and
hyperpigmentation, and
wishes to undergo laser treatments to remove them

3. Is willing to sign an informed consent form to participate in the study

4. 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:

1. Is hypersensitive to light exposure

2. Has an active sun tan

3. Has active localized or systemic infection

4. Is taking medication(s) for which sunlight is a contraindication

5. Has a history of squamous cell carcinoma or melanoma

6. Has a history of keloid scarring

7. 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, e.g., lack of noticeable skin flaking, skin peeling and
skin surface roughness.

8. Has had a laser procedure, a peel or has used lightening creams in the area to be
treated with in the past six months

9. Has a history of immunosuppression/immune deficiency disorders (including HIV
infection or AIDS) or use of immunosuppressive medications

10. Is female and pregnant is currently breast feeding or planning a pregnancy during the
study period

11. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine

12. Subjects with pigmented lesions that are considered not acceptable by the study
doctor or any condition that, in the study doctor's opinion, would make it unsafe to
treat.