# Ulthera Inc (specification developer, Raleigh, NC): 2 new FDA device listings, incl. system, imaging, pulsed echo, ultrasonic

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Ulthera Inc |
| Owner / operator | Merz North America, Inc. |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | Raleigh, NC, US |
| New listings | 2 |
| Devices | System, Imaging, Pulsed Echo, Ultrasonic; Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
| Product codes | IYO, OHV |
| Device classes | Class II |
| Medical specialties | Radiology, General, Plastic Surgery |
| Brand names | Ulthera System |
| First new listing | 2026-09-23 |
| Latest new listing | 2026-09-23 |
| FDA registration number | 1012187 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- 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.