The Emotional and Functional Benefits of Poly-L-Lactic Acid

Inclusion Criteria

• Subject must be an outpatient, male or female subjects of any race, 35 years of age or older.
• Subject must have any degree of facial volume loss.
• Subjects of all Fitzpatrick skin types are eligible.
• Subject must be able to follow study instructions and likely to complete all required visits, as assessed by the Investigator.
• Subject must sign an IRB-approved Informed Consent form, Photographic Release Form, and the Authorization for Use and release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed.

Exclusion Criteria

• Any of the previous facial treatments:

c. Any facial filler in the past 2 years d. Prior injection of permanent facial implant

• Have any skin pathology or condition that could interfere with the evaluation of the face.
• Be unable to communicate or cooperate with the Investigator due to a language barrier (non-English speaking), poor mental development, or impaired cerebral function.
• Have evidence of alcohol or drug abuse (Investigator opinion), or history of poor cooperation, non-compliance with medical treatment, or unreliability.
• Have used an investigational device, biologic or drug in the past 30 days, or be currently participating in an experimental drug, biologic or device trial.
• Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
• Be an employee (or a relative of an employee) of the Investigator, Sponsor or representative of the Sponsor.