MERZ NORTH AMERICA, INC.

Address:4133 Courtney St., Suite 10,FRANKSVILLE,WI,53126,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Implant, Dermal, For Aesthetic Use (LMH) (4) System, Vocal Cord Medialization (MIX) (1)

Premarket Exempt

Clear

Radiesse Injectable Implant1.5cc - M2138071M0H15 Catalog Number :

Device Description : Radiesse Injectable Implant is a volumizing filler intended for restoration and/ Radiesse Injectable Implant is a volumizing filler intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (1) injectable implant and (2) 27 gauge thin walled x 0.75 inch needles.

Device Class : 3

Duns Number: 028147846

Premarket Exempt : No

Product Code : LMH

Prescription Use : Yes

Device Count : 1

Radiesse Volume Advantage 1.5cc - M2138071M0K15 Catalog Number :

Device Description : Radiesse Injectable Implant is a volumizing filler indicated for subdermal impla Radiesse Injectable Implant is a volumizing filler indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (1) injectable implant and (2) 27 gauge thin walled x 0.75 inch needles.

Device Class : 3

Duns Number: 028147846

Premarket Exempt : No

Product Code : LMH

Prescription Use : Yes

Device Count : 1

Radiesse Volume Advantage - M2138071M0K25 Catalog Number :

Device Description : Radiesse Injectable Implant is a volumizing filler indicated for subdermal impla Radiesse Injectable Implant is a volumizing filler indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (2) injectable implants and (4) 27 gauge thin walled x 0.75 inch needles.

Device Class :

Duns Number: 028147846

Premarket Exempt : No

Product Code : LMH

Prescription Use : Yes

Device Count : 2

Prolaryn Gel Injectable Implant - M2138602M0K55 Catalog Number :

Device Description : Prolaryn Gel is a water-based injectable gel implant used in the vocal folds to Prolaryn Gel is a water-based injectable gel implant used in the vocal folds to treat vocal fold insuffiency. Prolaryn Gel resorbs within a period of 3-6 months and is a temporary implant.

Device Class : 2

Duns Number: 028147846

Premarket Exempt : No

Product Code : MIX

Prescription Use : Yes

Device Count : 1

Belotero Balance - M2138700M05 Catalog Number :

Device Description : Belotero Balance is a hyaluronic-acid based dermal filler approved for injection Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. Belotero Balance kit contains (1) injectable implant and 2 needles - 30 Gauge x 1/2 inch, and 27 Gauge x 1/2 inch.

Device Class : 3

Duns Number: 028147846

Premarket Exempt : No

Product Code : LMH

Prescription Use : Yes

Device Count : 1

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