PMA · Approved

Recalled · 2011

Radiesse 1.3CC and 0.3CC

P050037PMAApproved Dec 22, 2006449-day reviewClass IIIRecalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Merz North America, Inc. · LMH Implant, Dermal, For Aesthetic Use

Approved on Dec 22, 2006 through premarket approval, which rests on the device’s own clinical evidence after a 449-day review. It has been recalled 2 times.

Decided: Dec 22, 2006
Review: 449 days
Class: Class III
Product code: LMH
Recalls: 2

PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.

P050037 has 147 supplements since 2007: changes to the approved device, its labelling or its manufacturing, each approved separately.

PMA supplements approved per year

2007high 12 (2023) · low 2 (2007)2026

View FIG. 1 as a table

Year	Supplements approved
2007	2
2008	11
2009	6
2010	2
2011	3
2012	8
2013	10
2014	10
2015	10
2016	11
2017	7
2018	8
2019	6
2020	9
2021	3
2022	6
2023	12
2024	11
2025	6
2026	6

FIG. 1 — Supplements to P050037, 2007–2026Source: FDA PMA database

Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LMH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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Does it have a predicate?

PMA decisions do not claim a predicate device.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 18, 2011	Not classified	Z-0145-2012	Nonconforming Material/Component	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 potential for product that my leak pass the…
Apr 6, 2011	Not classified	Z-2221-2011	Employee error	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 it had been marked as approved…

No ancestor or descendant has a Class I recall.

How does its category compare?

All LMH devices

LMH Implant, Dermal, For Aesthetic Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMH

51in 2025

2007high 81 (2023) · low 15 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LMH

Too few LMH 510(k)s in any year since 2007 to give a median.

Recalls per year · LMH

1in 2015

2007high 2 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LMH

1,805in 2025

2007high 1,805 (2025) · low 175 (2007)2025

MAUDE reports naming product code LMH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	15	—	0	175
2008	50	—	0	308
2009	37	—	0	1,217
2010	19	—	0	736
2011	21	—	2	449
2012	44	—	0	402
2013	39	—	0	451
2014	61	—	0	786
2015	60	—	1	885
2016	45	—	0	691
2017	52	—	0	1,509
2018	57	—	0	1,803
2019	68	—	0	1,273
2020	61	—	0	1,156
2021	51	—	0	1,422
2022	40	—	0	1,358
2023	81	—	0	1,478
2024	74	—	0	1,372
2025	51	—	0	1,805
2026	56	—	0	—

https://510kreport.com/device/P050037 · printed Nov 6, 2026

Cite this page

510(k) Report. “P050037: Radiesse 1.3CC and 0.3CC.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P050037

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Record history

FDA decision record loaded May 2, 2026
Page last updated Nov 3, 2026