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  6. Restylane Lyft with Lidocaine - P040024/S099
  1. Device Approvals, Denials and Clearances

Restylane Lyft with Lidocaine - P040024/S099

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 North Freeway, Fort Worth, TX 76177 US
Approval Date: May 18, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf4/P040024S099a.pdf

What is it? Restylane® Lyft with Lidocaine is a clear injectable dermal filler gel. This supplement expands the indication for Restylane Lyft with Lidocaine to include being intended to help improve the appearance of aging hands with moderate to severe volume loss. Restylane® Lyft with Lidocaine consists of hyaluronic acid and lidocaine.

How does it work? A doctor uses an ultrafine needle with a diameter of 0.33 mm to inject Restylane® Lyft with Lidocaine into the back of the hand to add volume to the aging hand.

When is it used? Restylane® Lyft with Lidocaine may be used in adults 22 years of age or older with moderate to severe volume deficit of the hands.

What will it accomplish? Restylane® Lyft with Lidocaine may temporarily improve the appearance of the hand by increasing fullness in the back of the hand, with the effect usually lasting for 6-12 months. In a clinical study, patients needed one or two treatments to achieve the best outcome.

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

  • have severe allergies with a history of severe reactions (anaphylaxis), as an injection of Restylane® Lyft with Lidocaine may result in an allergic reaction.
  • are allergic to lidocaine or any of the proteins from the bacteria used to make the hyaluronic acid in Restylane® Lyft with Lidocaine (bacterial proteins), as an injection of Restylane® Lyft with Lidocaine may result in an allergic reaction.
  • are prone to bleeding or have been diagnosed with a bleeding disorder, as an injection of Restylane® Lyft with Lidocaine may have a higher risk of severe bleeding or bruising.

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