# Merz North America, Inc. (other, Sturtevant, WI): 4 new FDA device listings, incl. implant, dermal, for aesthetic use

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Merz North America, Inc. |
| Role | Other |
| Establishment types | Complaint File Establishment per 21 CFR 820.198 |
| Location | Sturtevant, WI, US |
| New listings | 4 |
| Devices | Implant, Dermal, For Aesthetic Use; System, Imaging, Pulsed Echo, Ultrasonic; Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
| Product codes | LMH, IYO, OHV |
| Device classes | Class II, Class III |
| Medical specialties | Radiology, General, Plastic Surgery |
| Brand names | Belotero Volume (+) Lidocaine; Belotero Intense (+) Lidocaine; Ulthera System |
| First new listing | 2026-05-27 |
| Latest new listing | 2026-09-23 |
| FDA registration number | 3013840437 |
| Registration expires | 2027-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.