12/7/23, 2:00 PM SKINVIVE by JUVÉDERM – P110033/S059 | FDA
SKINVIVE by JUVÉDERM – P110033/S059
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: SKINVIVE by JUVÉDERM
PMA Applicant: Allergan Aesthetics
Address: 2525 Dupont Drive
Irvine, CA 92612 USA
Approval Date: May 11, 2023
Approval Letter: Approval Order
(https://www.accessdata.fda.gov/cdrh_docs/pdf11/P110033S059A.pdf)
What is it?
SKINVIVE by JUVÉDERM is a gel implant or dermal filler (/medical-devices/aesthetic-
cosmetic-devices/dermal-fillers-soft-tissue-fillers) that is injected in specific areas of facial
tissue to add definition or reduce the appearance of lines and wrinkles. It consists of the
chemical hyaluronic acid, 1,4-butanediol diglycidyl ether (BDDE), and 0.3% of the drug
lidocaine (https://medlineplus.gov/druginfo/meds/a682701.html) to reduce pain on injection.
This approval expands the use of this product to include injections between the layers of the skin
(intradermal) to improve the smoothness of the cheeks.
https://www.fda.gov/medical-devices/recently-approved-devices/skinvive-juvederm-p110033s059 1/3
12/7/23, 2:00 PM SKINVIVE by JUVÉDERM – P110033/S059 | FDA
How does it work?
A doctor injects SKINVIVE by JUVÉDERM between the layers of skin (intradermally) in the face
to produce the appearance of smoother skin.
When is it used?
SKINVIVE by Juvéderm injectable gel is indicated for intradermal injection to improve facial
skin smoothness of the cheeks in people 21 years of age and older.
What will it accomplish?
When evaluated in a clinical study of 209 people, SKINVIVE by Juvéderm was found to be
effective at improving facial skin smoothness in the cheeks. This effect lasted for at least six (6)
months.
When should it not be used?
SKINVIVE by Juvéderm should not be used for people who have:
Severe allergies with a history of anaphylaxis
A history or known presence of multiple severe allergies
A known sensitivity or allergy to gram-positive bacterial proteins
Any known allergies to lidocaine
Additional information (including warnings, precautions, and
adverse events):
Summary of Safety and Effectiveness Data (SSED)
(https://www.accessdata.fda.gov/cdrh_docs/pdf11/P110033S059B.pdf)
Labeling (https://www.accessdata.fda.gov/cdrh_docs/pdf11/P110033S059C.pdf)
(Clinician Labeling)
Labeling (https://www.accessdata.fda.gov/cdrh_docs/pdf11/P110033S059D.pdf) (Patient
Labeling)
PMA Database Entry
(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110033S059)
Dermal Fillers (Soft Tissue Fillers) (/medical-devices/aesthetic-cosmetic-devices/dermal-
fillers-soft-tissue-fillers)
https://www.fda.gov/medical-devices/recently-approved-devices/skinvive-juvederm-p110033s059 2/3
12/7/23, 2:00 PM SKINVIVE by JUVÉDERM – P110033/S059 | FDA
Was this helpful? Yes No
https://www.fda.gov/medical-devices/recently-approved-devices/skinvive-juvederm-p110033s059 3/3
