Restylane Refyne, Restylane Defyne Injectable Gels

Trade Name

Restylane Defyne EUDAMED

Restylane Refyne, Restylane Defyne PMA

Generic Name

Implant, dermal, for aesthetic use

Model / Reference

012095

Primary DI / UDI-DI

D-012095LM

Basic UDI-DI

B-012095LM

PMA Number

P140029 ↗

FDA Product Code

LMH

EMDN Code

X0303 Substances, combinations of substances, or items without an intended medical purpose intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, by a prefilled means for introduction, excluding those for tattooing – resorbable

Device Class

Class III

Market of Registration

Germany

Advisory Committee

General, Plastic Surgery

FDA Decision

APPR Approved

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  CE/MDR 2268181CE02 Active Valid to Aug 2030 CE/MDR 2268181TD02 Active Valid to Dec 2030

• Restylane Refyne

  Class III

  CE/MDD

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• What is the intended use of Restylane Refyne and Restylane Defyne?

  Restylane Refyne is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in patients over the age of 21. Restylane Defyne is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe, deep facial wrinkles and folds (such as nasolabial folds) in patients over the age of 21, as stated in the approval statement.

• Are Restylane Refyne and Restylane Defyne reusable or single-use devices?

  The devices are supplied as sterile, single-use pre-filled syringes, as implied by their classification as injectable dermal gels and standard regulatory practice for such products; reuse is not indicated or permitted based on the provided data.

• What regulatory approvals do Restylane Refyne and Restylane Defyne have?

  The devices have FDA PMA approval (application number P140029, decision date 2016-12-09) and comply with MDD requirements, as explicitly stated in the AUTHORIZATIONS field and supported by the PMA number and decision code APPR.