# Merz North America, Inc.

- Location (FDA's records): Franksville
- FDA decisions: 7 (2005–2026): 1 510(k) clearance and 6 original PMA approvals
- Product codes: LMH (5), LNM (1), PKO (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- On Light Sciences, Inc.: 1 (https://510kreport.com/company/on-light-sciences)

## Recent decisions
- P250016: Belotero® Intense (+) Lidocaine (Jul 9, 2026)
- P250020: Belotero Volume (+) Lidocaine (May 19, 2026)
- K172689: DESCRIBE PFD Patch (Nov 29, 2017)
- P090016: Belotero Balance (Nov 14, 2011)
- P050052: Radiesse Injectable Implant (Dec 22, 2006)
- P050037: Radiesse 1.3CC and 0.3CC (Dec 22, 2006)
- P040047: Coaptite (Nov 10, 2005)

Source page: https://510kreport.com/company/merz-north-america