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Evolysse Form and Evolysse Smooth

FDA PMA

Class III (US FDA PMA)

PMA P240022

by Symatese

Identity

Trade Name
EVOLYSSE™ SMOOTH and EVOLYSSE™ FORM FDA PMA
Generic Name
Implant, dermal, for aesthetic use FDA PMA

Identifiers

PMA Number
P240022 FDA PMA
FDA Product Code
LMH FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
General, Plastic Surgery FDA PMA
FDA Decision
APPR Approved FDA PMA

The Evolysse Form and Evolysse Smooth are dermal implants designed for aesthetic use, classified as Class III medical devices. These injectable hyaluronic acid gels are intended for dermal and subdermal administration to correct moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLFs), in adults aged 22 years or older.

Administered via injection, these devices are supplied in sterile, single-use formulations. They are regulated under an FDA Premarket Approval (PMA) application (P240022) and are intended for use in clinical settings by trained healthcare professionals. The devices are not MRI-safe, and their specific lot numbers and registration codes are tracked through the FDA’s OpenFDA database. Storage and handling must comply with sterile medical device protocols.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Introducing Evolysse™, Evolysse Difference, SYMATESE Secures FDA Approval for EVOLYSSE™, Evolysse for HCP - evolus.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Symatese

Sources (1)

  • FDA PMA P240022 24 fields · synced Sep 18, 2026