Post Market Clinical Follow Up Study to Collect Additional Data and Imaging

Recruitment & Eligibility

Inclusion Criteria

A healthy male or female 18 - 65 years of age.
Willing to undergo treatments for pigmentation and/or mild to moderate wrinkles on the face with the PicoSure device.
Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
Understands and accepts the obligation and is logistically able to be present for all visits.
Is willing to comply with all requirements of the study and sign the informed consent document.

Exclusion Criteria

Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
The subject is hypersensitive to light in the near infrared wavelength region.
The subject takes medication which is known to increase sensitivity to sunlight.
The subject has seizure disorders triggered by light.
The subject takes or has taken oral isotretinoin, such as Accutane®, within the last six months.
The subject has an active localized or systemic infection, or an open wound in area being treated.
The subject has a significant systemic illness, such as lupus, or an illness localized in area being treated.
The subject has common acquired nevi that are predisposed to the development of malignant melanoma.
The subject has herpes simplex in the area being treated.
The subject is receiving or has received gold therapy.
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 in the area to be treated 6 months to entering this study.
The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.

Arm && Interventions

Group	Intervention	Description
PicoSure Device	RF Non-Invasive Treatment	The PicoSure device will be used on the face for the treatment of pigmentation and mild to moderate wrinkles.

Primary Outcome Measures

Name	Time	Method
Correct Identification of Baseline Photographs vs. Photographs Taken 3 Months Post Last Treatment	3 month follow up	Three blinded independent reviewers will perform a photographic evaluation in which they will be asked to identify pre-treatment images when compared to post treatment images. The percentage of photographs that were correctly identified as either baseline photographs or photographs taken at the 3 month follow up will be reported. Identifying whether the photograph was taken at the baseline vs. 3 month follow up was only done at the 3 month follow up point.

Secondary Outcome Measures