A Post Market Device Study for the Treatment of Acne

Inclusion Criteria

• •1. Female or Male, Fitzpatrick Skin Types I-VI, 16 to 60 years of age (inclusive).
• •2. Has clinically diagnosed acne vulgaris of severity grade 3 - 4 (moderate to severe) on the face based on photographic review by expert dermatologist grader(s) using the Investigator's Global Assessment Scale.
• •3. Has ≥ 10 inflammatory acne lesions on the face as determined by the Investigator (or qualified designee).
• •4. Subject (and parent or legal guardian if subject is a minor under age 18) must be able to read, speak, and understand English and sign the Informed Consent Form.
• •5. Willing and able to adhere to the treatment and follow-up schedule and pre/post-treatment care instructions.
• •6. Willing to have very limited sun exposure (including avoiding tanning booths, sun lamps, sunbathing) and use an investigator approved sunblock or sunscreen of SPF 30 or higher on the face every day for the duration of the study, including the follow-up period.
• •7. Must maintain the same acne treatment regimen, including topical and systemic medications for at least 2 weeks prior to enrollment, and for the duration of the study, including the follow-up period unless approved by the Investigator.
• •8. Willing to have photographs taken of the face and agree to the use of photographs for presentation, educational or marketing purposes.
• •9. Agree to not undergo any other procedure(s) or add any new treatment modalities in the target area during the study unless approved by Investigator.
• •10. Willing to use investigator approved skincare topicals and follow investigator approved skincare regimen for the duration of the study.