AVAVA MIRIA General Use
A general protocol to treat a variety of dermatologic conditions and collect patient feedback. Primary outcome is the collection and analysis of patient questionnaires related to the overall experience of the device treatment. Secondary outcome measures include physician and subject evaluations in regards to improvement seen in the device as well as assessment of side effects.
• Male or female subjects between 18 to 70 years of age.
• Dermatologic condition that can be addressed by the laser, including but not limited to:
‣ Wrinkles
⁃ Scars
⁃ Acne Scars
⁃ Active Acne
⁃ Dyschromia
⁃ Cutaneous Lesions such as Age or Sun Spots
⁃ Melasma
⁃ Laxity
• Willingness to have digital photographs taken of treatment area(s) and agreement with use of photographs for presentation, educational, or marketing purposes.
• Willingness to comply with the following during the study, including the follow-up period:
‣ maintain consistent skin care regimen on treated areas.
⁃ cover treated areas or have very limited sun exposure and, if requested, use an approved sunscreen of SPF 50 or higher.
⁃ refrain from using systemic corticosteroids, according to Investigator discretion.
⁃ refrain from using topical corticosteroids, retinoids, or prescription skin-lightening medications on the treated areas, according to Investigator discretion.
⁃ refrain from any other procedures in the treatment areas.
• Willingness and ability to comply with study instructions and return for required visits.
• Subject has read and signed a written informed consent form.
• Subject lives within 50 miles of study site.
• Willingness to shave hair in intended treatment area