Aesthetic device

Clinical studies for aesthetic devices often rely on outcomes that are partly subjective, such as appearance ratings, which affects how endpoints and blinding are designed. In the EU, some products without a medical purpose are covered by Annex XVI of the MDR, which is a separate question from this FDA glossary term.

Device intended to provide a desired change in visual appearance in the subject through physical modification of the structure of the body.

FDA guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices (November 2013), Section 11, Glossary