Pan-Facial Layering of Hyaluronic Acid Filler

Inclusion criteria

• Participants must voluntarily sign and date an informed consent, approved by an independent ethics committee, prior to the initiation of any screening or study-specific procedures.
• Participants must be adult male or female, at least 18 years old.
• Participants must be willing and able to comply with procedures required in the protocol.
• Participants must be in good health as per investigator's judgment based on medical history.
• Participants must not have uncontrolled systemic disease.
• Participants do not present with or have a history of any medical condition that may place the participant at increased risk following exposure to hyaluronic acid or interfere with the study evaluation, including:

• Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
• History of facial nerve palsy
• Infection or dermatological condition at the treatment injection sites
• Marked facial dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, or excessively photodamaged skin
• Participants do not have history of clinically significant medical conditions or any other reason that the investigator determines would interfere with the participants participation in this study or would make the participant an unsuitable candidate to receive the study medical device.
• Participants do not have history of an allergic reaction or significant sensitivity to constituents of the study medical device (or its excipients), including local anaesthetic agents found in the product (Lidocaine).
• Participants must not have tattoos, jewellery, or clothing which obscure the treatment area and cannot be removed.
• Participants do not have anticipated need for surgery or overnight hospitalization during the study.
• Participants do not have history of surgical procedures in the face, including any lifting procedure (e.g., facial lift, suture lift, thread lift, brow lift, eyelid and/or eyebrow surgery).
• Participants have not had, in the last 2 years, facial treatment with semi- permanent or permanent soft tissue fillers (e.g., poly-L-lactic acid, polyalkylimide, polymethylmethacrylate, polytetrafluoroethylene, and silicone), synthetic implantation and/or autologous fat transplantation.
• Participant has not received treatment with energy-based devices in the last 6 months.
• Participant has not received soft tissue filler within the last 12 month in the face.
• Female participants of child-bearing potential must have a negative urine pregnancy test prior to any dose of study drug.
• Female participants of childbearing potential must practice at least 1 protocol-specified method of birth control that is effective from Baseline through at least 30 days after the last dose or until the end of study, whichever is longer. Female participants of non-childbearing potential do not need to use birth control.
• Female participants that are not pregnant or breastfeeding and are not considering becoming pregnant or donating eggs during the study or for approximately 30 days after the last dose of study medical device or until the end of study, whichever is longer.
• Participants must not have been treated with any investigational product within 30 days prior to the first dose of study medical device or is currently enrolled in another clinical study
• Participants must not be presenting with porphyria.
• Participants must not present with active disease, such as inflammation, infection or tumours, cold sores in or near the intended treatment sites.
• Participants must not have bleeding disorders or take thrombolytics or anticoagulants.
• Participants agree to abstain from taking any over the counter NSAIDs at least two weeks prior to any treatment administration (e.g. Advil)
• Participants must not have need to take immunosuppressants.

Exclusion criteria

• Participants with known active COVID infection within 14 days of baseline treatment.
• Participants has a history of cystic acne.
• Participant has had or is planning to have dental procedures, including teeth cleaning procedures at least 2 weeks before or after any scheduled treatment administration.