Medical Devices

Dermal Fillers Approved by the Center for Devices and Radiological Health

Close up of the nose, cheek, and mouth region of an elderly person

FDA approval is based on the review of data collected from controlled clinical studies that evaluated the safe and effective use of the wrinkle fillers when injected into specified areas of facial tissue.

More information about the FDA approval is based on the review of data collected from controlled clinical studies that evaluated the safe and effective use of the dermal fillers when injected into specified areas of facial tissue.

The Summary of Safety and Effectiveness Data for each approved dermal filler contains links to additional information about the clinical data the FDA reviewed.  Links to this information can be found under the “Trade Name” column in the table below. This table lists all FDA-approved dermal fillers. It should be noted that not all of the dermal fillers listed below are currently marketed. 

 
Trade Name (with link to additional information)MaterialApplicantPMA NumberDecision DateApproved For
RESTYLANE SILKHyaluronic Acid with LidocaineValeant Pharmaceuticals North America LLC/MedicisP040024 S0726/13/2014Indicated for lip augmentation and dermal implantation for correction of perioral rhytids (wrinkles around the lips) in patients over the age of 21.
JUVEDERM VOLUMNA XCHyaluronic Acid with LidocaineAllerganP11003310/22/2013Indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face in adults over the age of 21.

RESTYLANE-L INJECTABLE GEL

Hyaluronic Acid with LidocaineMedicis Aesthetics Holdings, Inc.P040024 S0568/30/2012Injection into the mid to deep dermis for correction of moderate to severe facial wrinkles/folds (such as nasolabial folds) and for lip augmentation in those over the age of 21 years.
BELOTERO BALANCEHyaluronic AcidMerz PharmaceuticalsP09001611/14/2011Injection into facial tissue to smooth wrinkles and folds, especially around the nose and mouth (nasolabial folds).
RESTYLANE INJECTABLE GELHyaluronic AcidMedicis Aesthetics Holdings, IncP040024 S05110/11/2011Lip augmentation in those over the age of 21 years.
SCULPTRA AESTHETICPoly-L-Lactic Acid (PLLA)Sanofi Aventis U.S.P030050 S0027/28/2009Use in shallow to deep nasolabial fold contour deficiencies and other facial wrinkles.
EVOLENCE COLLAGEN FILLERCollagenColbar Lifescience lP0700136/27/2008The correction of moderate to deep facial wrinkles and folds (such as nasolabial folds).
PREVELLE SILKHyaluronic Acid with LidocaineGenzyme BiosurgeryP030032 S0072/26/2008Injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
RADIESSE 1.3CC AND 0.3CCHydroxylapatiteBioform Medical, IncP05003712/22/2006Restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with HIV.
RADIESSE 1.3CC AND 0.3CCHydroxylapatiteBioform Medical, IncP05005212/22/2006Subdermal implantation for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
ELEVESSHyaluronic Acid with LidocaineAnika TherapeuticsP05003312/20/2006Use in mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
ARTEFILLPolymethylmethacrylate Beads, Collagen and Lidocaine.Suneva Medical, Inc.P02001210/27/2006Use in facial tissue around the mouth (i.e., nasolabial folds).
JUVEDERM 24HV, JUVEDERM 30, and JUVEDERM 30HVHyaluronic AcidAllerganP0500476/2/2006Use in mid to deep dermis for correction of  moderate to severe facial wrinkles and folds (such as nasolabial folds).
RESTYLANE INJECTABLE GELHyaluronic AcidMedicis Aesthetics Holdings, IncP0400243/25/2005Injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
CAPTIQUE INJECTABLE GELHyaluronic AcidGenzyme BiosurgeryP030032 S00211/12/2004Injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
SCULPTRAPoly-L-Lactic Acid (PLLA)Sanofi Aventis U.S.P0300508/3/2004Restoration and/or correction of the signs of facial fat loss (facial lipoatrophy) in people with Human Immunodeficiency Virus (HIV).
HYLAFORM (HYLAN B GEL)Modified hyaluronic acid derived from a bird (avian) sourceGenzyme BiosurgeryP0300324/22/2004Injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
RESTYLANE INJECTABLE GELHyaluronic AcidQ-med AbP02002312/12/2003Injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
COSMODERM 1 HUMAN-BASED CCollagenInamed CorporationP800022 S0503/11/2003Injection into the superficial papillary dermis for correction of soft tissue contour deficiencies, such as wrinkles and acne scars.
FIBRELCollagenSerono LaboratoriesP8500532/26/1988The correction of depressed cutaneous scars which are distendable by manual stretching of the scar borders.
ZYPLAST(R)CollagenCollagen Corp.P800022 S0116/24/1985Use in mid to deep dermal tissues for correction of contour deficiencies.
ZYDERM COLLAGEN IMPLANT CollagenAllerganP8000229/18/1981Use in the dermis for correction of contour deficiencies of this soft tissue.