Medical Devices

Restylane Lyft with Lidocaine Injectable Gel Injectable Dermal Filler - P040024/S073

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Restylane Lyft with Lidocaine
PMA Applicant: Galderma Laboratories, L.P.
Address: 14501 N. Freeway Fort Worth, Texas 76177
Approval Date: July 1, 2015
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040024S073a.pdf

What is it? Restylane Lyft with Lidocaine is a hyaluronic acid gel that is injected into moderate to severe facial folds and wrinkles. It may also be injected into the cheek to temporarily correct age-related volume loss in patients over the age of 21. This product also contains a small amount of a local anesthetic (lidocaine) to help to reduce the pain of the injection.

How does it work? A doctor (dermatologist or plastic surgeon) injects Restylane Lyft with Lidocaine into the facial tissue underneath the wrinkle and/or the cheek. The product works by temporarily adding volume to the injection area.

When is it used? Restylane Lyft with Lidocaine is used in patients with moderate to severe facial folds and wrinkles, or in patients over the age of 21 who have age-related volume loss.

What will it accomplish? Restylane Lyft with Lidocaine may help smooth the appearance of moderate to severe smile lines (nasolabial folds). It also may improve the visual appearance of cheek fullness. The side-effects of Restylane Lyft with Lidocaine include:

  • lumps at the injection site
  • redness
  • swelling
  • pain
  • tenderness
  • itching 

When should it not be used?
Restylane Lyft with Lidocaine should not be used in patients who have:

  • severe allergies, such as a history of severe hypersensitivity (anaphylaxis) or history or presence of multiple severe allergies
  • a history of allergies to gram positive bacteria
  • bleeding disorders
  • previous hypersensitivity to local anesthetics of the amide type, such as lidocaine

Additional information (including warnings, precautions and adverse events): Summary of Safety and Effectiveness Data and Labeling are available online.

Page Last Updated: 07/28/2015
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