Post-Market Clinical Follow-up (PMCF) Study of Safety and Performance of 300-01 RefillHA Lips

A Post-Market Observational Study of the Safety and Efficacy of RefillHA Lips for Remodelling and Correction of Mild Defects of the Lips

Inclusion Criteria: * Men or women of any race, 18 years of age or older. * Able to read, understand and sign informed consent. Exclusion Criteria: * Subjects with known contraindications to the treatment with RefillHA Lips, as per the device IFU. * Patients with multiple and/or severe allergies or history of anaphylaxis. * Pregnant or lactating women (contraindications as per IFU). * Having received prior dermal filler injections in the six months preceding the study. * Previously treated with semi-permanent or permanent filler in the intended injection area. * Presenting with a cutaneous disorder, inflammation or infection near to the treatment area. * Known hypersensitivity to lidocaine and/or lidocaine HCl or hyaluronic acid. * Metabolic or endocrine uncontrolled disease, anaphylaxis, severe allergies or uncontrolled immune disorder. * Undergoing or planning to undergo peeling treatment or laser-/ultrasound-based treatment within 3 weeks before or after injection. * Have received anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti- inflammatory drugs (NSAIDs such as aspirin, ibuprofen), or other substances known to prolong time of coagulation from a week before treatment. A wash-out period of a week is allowed. * Subject who has a condition or is in a situation that, in the investigator's opinion, may put the subject at significant risk, or may significantly interfere with the subject's participation in the study or with protocol evaluation parameters.