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) Material Applicant PMA Number Decision Date Approved For
RESTYLANE SILK Hyaluronic Acid with Lidocaine Valeant Pharmaceuticals North America LLC/Medicis P040024 S072 6/13/2014 Indicated for lip augmentation and dermal implantation for correction of perioral rhytids (wrinkles around the lips) in patients over the age of 21.
JUVEDERM VOLUMNA XC Hyaluronic Acid with Lidocaine Allergan P110033 10/22/2013 Indicated 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 Lidocaine Medicis Aesthetics Holdings, Inc. P040024 S056 8/30/2012 Injection 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 BALANCE Hyaluronic Acid Merz Pharmaceuticals P090016 11/14/2011 Injection into facial tissue to smooth wrinkles and folds, especially around the nose and mouth (nasolabial folds).
RESTYLANE INJECTABLE GEL Hyaluronic Acid Medicis Aesthetics Holdings, Inc P040024 S051 10/11/2011 Lip augmentation in those over the age of 21 years.
SCULPTRA AESTHETIC Poly-L-Lactic Acid (PLLA) Sanofi Aventis U.S. P030050 S002 7/28/2009 Use in shallow to deep nasolabial fold contour deficiencies and other facial wrinkles.
EVOLENCE COLLAGEN FILLER Collagen Colbar Lifescience l P070013 6/27/2008 The correction of moderate to deep facial wrinkles and folds (such as nasolabial folds).
PREVELLE SILK Hyaluronic Acid with Lidocaine Genzyme Biosurgery P030032 S007 2/26/2008 Injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
RADIESSE 1.3CC AND 0.3CC Hydroxylapatite Bioform Medical, Inc P050037 12/22/2006 Restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with HIV.
RADIESSE 1.3CC AND 0.3CC Hydroxylapatite Bioform Medical, Inc P050052 12/22/2006 Subdermal implantation for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
ELEVESS Hyaluronic Acid with Lidocaine Anika Therapeutics P050033 12/20/2006 Use in mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
ARTEFILL Polymethylmethacrylate Beads, Collagen and Lidocaine. Suneva Medical, Inc. P020012 10/27/2006 Use in facial tissue around the mouth (i.e., nasolabial folds).
JUVEDERM 24HV, JUVEDERM 3 Hyaluronic Acid Allergan P050047 6/2/2006 Use in mid to deep dermis for correction of  moderate to severe facial wrinkles and folds (such as nasolabial folds).
RESTYLANE INJECTABLE GEL Hyaluronic Acid Medicis Aesthetics Holdings, Inc P040024 3/25/2005 Injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
CAPTIQUE INJECTABLE GEL Hyaluronic Acid Genzyme Biosurgery P030032 S002 11/12/2004 Injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
SCULPTRA Poly-L-Lactic Acid (PLLA) Sanofi Aventis U.S. P030050 8/3/2004 Restoration 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) source Genzyme Biosurgery P030032 4/22/2004 Injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
RESTYLANE INJECTABLE GEL Hyaluronic Acid Q-med Ab P020023 12/12/2003 Injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
COSMODERM 1 HUMAN-BASED C Collagen Inamed Corporation P800022 S050 3/11/2003 Injection into the superficial papillary dermis for correction of soft tissue contour deficiencies, such as wrinkles and acne scars.
FIBREL Collagen Serono Laboratories P850053 2/26/1988 The correction of depressed cutaneous scars which are distendable by manual stretching of the scar borders.
ZYPLAST(R) Collagen Collagen Corp. P800022 S011 6/24/1985 Use in mid to deep dermal tissues for correction of contour deficiencies.
ZYDERM COLLAGEN IMPLANT Collagen Allergan P800022 9/18/1981 Use in the dermis for correction of contour deficiencies of this soft tissue.

Page Last Updated: 08/06/2014
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