# P050037: Radiesse 1.3CC and 0.3CC

- Pathway: PMA
- Applicant: Merz North America, Inc.
- Decided: Dec 22, 2006 after 449 days
- Product code: LMH (Implant, Dermal, For Aesthetic Use)
- Device class: 3
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Aug 18, 2011 · Not classified · Z-0145-2012: There is a potential leakage of product that may occur with Merz Aesthetics 1.5cc syringes of Radiesse Dermal Filler. When using the syringe, Health Care Professionals should be alerted to the potenti
- Apr 6, 2011 · Not classified · Z-2221-2011: Merz Aesthetics, Inc. is recalling 1 lot (1034417) of Radiesse 1.3 cc Implant. The lot was supposed to be scrapped because it had failed to meet its Loss On Drying (LOD) specification. Unfortunately i

Source page: https://510kreport.com/device/P050037
Methodology: https://510kreport.com/methodology