Lasers to Aid in Treatment of Acne Scars

Inclusion Criteria:

• Adult males and females aged 18 or older
• Subjects in good general health based on investigator's judgment and medical history
• Moderate to severe atrophic acne scarring on the face per ECCA (échelle d'évaluationclinique des cicatrices d'acné) acne grading scale
• Understands and accepts obligation not to receive any other procedures on thetreatment area through the length of the study
• Understands and accepts the obligation and is logistically able to be present for allvisits
• Is willing to comply with all requirements of the study and sign the informed consentdocuments
• Must be willing to maintain usual sun exposure for the duration of the study
• Subject agrees to avoid tanning or use of sunless tanner during the entire course ofthe study
• Negative urine pregnancy test result at the time of study entry (if applicable)
• For female subjects of childbearing potential, must be willing to use an acceptableform of birth control during the entire course of the study. All systemic birthcontrol measures must be in consistent use for at least 30 days prior to studyenrollment.

1. A female is considered of childbearing potential unless she is postmenopausal,without a uterus and/or both ovaries, or has had a bilateral tubal ligation.
2. Acceptable methods of birth control are: oral contraceptives, contraceptivepatches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g.,condoms and spermicide), abstinence, and/or vasectomy of partner with adocumented second acceptable method of birth control, should the subject becomesexually active.

Exclusion Criteria:

• Female subjects who are pregnant, planning a pregnancy, or breast feeding during thestudy
• The subject is hypersensitive to light in the near infrared wavelength region
• The subject is taking medication which is known to increase sensitivity to sunlight
• The subject has a seizure disorders triggered by light
• The subject is receiving or have received gold therapy
• The subject has a pacemaker
• The subject has a metal implant that interferes with the transmission of energy to theelectrical field
• The subject has any embedded electronic devices that give or receive a signal such asImplantable Cardiac Defibrillators (ICD) or Cardiac Resynchronization Therapy (CRT)devices: treatment may interfere with the functionality of the device and/or damagethe electronic implant
• Gold allergy
• The subject has nerve insensitivity to heat in the treatment area or in the neutralpad placement area or a neuropathic disorder
• The subject has severe laxity or sagging that causes redundant folds of tissue orhanging skin in the area to be treated
• Dermal fillers, neuromodulator, biostimulatory injectables, fat grafting,radiofrequency device treatments, microfocused ultrasound device treatments, laser andlight-based device treatments, microneedling to the face during the 6-month periodbefore study treatment m) Subjects with tattoos in the treatment areas n) Subjectswith a significant history or current evidence of a medical, psychological, or otherdisorder that, in the investigator's opinion, would preclude enrollment into the study
• Subjects with a history of or presence of any skin condition/disease (including butnot limited to any visible rash, atopic dermatitis, psoriasis, actinic keratoses,keratinocyte carcinoma, melanoma, etc.) in the treatment area that might interferewith the diagnosis or evaluation of study parameters
• History of keloid or hypertrophic scarring
• Subjects with an active bacterial, viral, or fungal infection of the treatment areas
• The subject has a significant systemic illness, such as lupus, or an illness localizedin area being treated
• History of lidocaine sensitivity deemed by the investigator to preclude the subjectfrom enrolling into the study
• Subjects planning any cosmetic procedure to the treatment areas during the studyperiod, other than the treatment that will be performed by the investigator
• Presence of incompletely healed wound(s) in the treatment area
• Current participation or participation within 30 days prior to the start of this studyin a drug or other investigational research study