Skip to content

Restylane Injectable Gel

by Q-Med AB Sweden PMA

PMA P040024

Product code LMH

Overview

Restylane Injectable Gel is a dermal implant designed for aesthetic use. It is indicated for mid-to-deep dermal implantation to correct moderate to severe facial wrinkles and folds, such as nasolabial folds.

Supplied as an injectable gel, the device is intended for single-use administration by qualified healthcare professionals. It is regulated under FDA PMA (P040024) and classified as a Class III device for dermal implantation in aesthetic procedures.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically 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.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP040024 Date25 Mar 2005ApprovedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA PMA Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

PMA · synced 22 Oct 2026

Full name
Restylane, Perlane, Restylane L, Perlane L
Trade Name
Restylane Injectable Gel
Generic Name
Implant, dermal, for aesthetic use
PMA Number
FDA Product Code
LMH
Device Class
Class III
Advisory Committee
General, Plastic Surgery
FDA Decision
APPR Approved

Other devices from Q-Med AB

See all devices from Q-Med AB →

Questions

  • What is Restylane Injectable Gel used for?

    Restylane Injectable Gel is indicated for mid-to-deep dermal implantation to correct moderate to severe facial wrinkles and folds, such as nasolabial folds, based on the device's approval documentation.

  • Who manufactures Restylane Injectable Gel?

    Restylane Injectable Gel is manufactured by Q-Med AB, located in Uppsala, Sweden, as specified in the device data.

  • Is Restylane Injectable Gel a single-use device?

    Yes, Restylane Injectable Gel is supplied as an injectable gel intended for single-use administration, consistent with its classification as a dermal implant for aesthetic use.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA PMA P040024 24 fields · synced 22 Oct 2026