Wrinkle Fillers Approved by the Center for Devices and Radiological Health

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 data FDA reviewed to approve each dermal filler exists in the Summary of Safety and Effectiveness Data, which is linked in the additional information listed with each product.

 

 

 

Trade Name (with link to additional information)	Material	Applicant	PMA Number	Decision Date	Approved For:
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.