← Back to catalogue

Radiesse Volume Advantage 1.5cc

FDA UDI

Class III (US FDA UDI)

by Merz North America, Inc.

Identity

Trade Name
Radiesse Volume Advantage 1.5cc FDA UDI
Generic Name
Dermal tissue reconstructive material, synthetic mineral FDA UDI
Device Name
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. RADIESSE injectable implant is also indicated for hand augmentation to correct volume loss in the dorsum of the hands. FDA UDI
Model / Reference
8071C0K1 FDA UDI
Description
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. RADIESSE injectable implant is also indicated for hand augmentation to correct volume loss in the dorsum of the hands. FDA UDI

Identifiers

Primary DI / UDI-DI
M2138071C0K15 FDA UDI
PMA Number
P050037 FDA UDI
P050052 FDA UDI
FDA Product Code
PKY FDA UDI
LMH FDA UDI
GMDN Term
Dermal tissue reconstructive material, synthetic mineral FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 1.5 Milliliter FDA UDI

Category: Dermal tissue reconstructive material, synthetic mineral

Radiesse Volume Advantage 1.5cc by Merz North America, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dermal tissue reconstructive material, synthetic mineral.

Cleared under the same submission

P050037 also covers:

P050052 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Merz North America, Inc.

Sources (1)

  • FDA UDI 09706c87-f805-4999-9ac7-66346182afb8 37 fields · synced Jun 9, 2026