Data / Medical devices / United States / Ulthera Inc
Ulthera Inc: FDA-registered device maker in Raleigh, NC, United States, 10 510(k) clearances
Ulthera Inc is registered with the FDA (registration 1012187) in Raleigh, NC, United States. It lists 2 device types. The FDA files 10 510(k) clearances under its listings, the newest dated May 21, 2026. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1012187
- Address
- 6501 Six Forks Rd, Raleigh, NC, United States, 27615
- Owner or operator
- Merz North America, Inc. (9043404)
- Roles
- Specification developer
- First device listed
- January 15, 2016
- Registered through
- 2027
- Brand names listed
- Ulthera System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | OHV | 2 | Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 21, 2026 | K260618 | Ulthera® System | OHV | Substantially Equivalent | Ulthera, Inc. | accessdata.fda.gov |
| May 13, 2025 | K250418 | Ulthera System (UC-1 Control Unit PRIME Model 2.1) | OHV | Substantially Equivalent | Ulthera, Inc. | accessdata.fda.gov |
| February 24, 2025 | K243035 | Ulthera® System | OHV | Substantially Equivalent | Ulthera, Inc. | accessdata.fda.gov |
| February 22, 2024 | K233996 | Ulthera System (UC-1 Control Unit PRIME) | OHV | Substantially Equivalent | Ulthera, Inc. | accessdata.fda.gov |
| May 4, 2018 | K180623 | Ulthera System | OHV | Substantially Equivalent | Ulthera, Inc. | accessdata.fda.gov |
| June 20, 2014 | K134032 | ULTHERA SYSTEM | OHV | Substantially Equivalent | Ulthera, Inc. | accessdata.fda.gov |
| December 11, 2013 | K132028 | ULTHERA SYSTEM | OHV | Substantially Equivalent | Ulthera, Inc. | accessdata.fda.gov |
| October 2, 2012 | K121700 | ULTHERA SYSTEM | OHV | Substantially Equivalent | Ulthera, Inc. | accessdata.fda.gov |
| August 28, 2012 | K122528 | ULTHERA SYSTEM | OHV | Substantially Equivalent | Ulthera, Inc. | accessdata.fda.gov |
| September 11, 2009 | DEN080006 | ULTHERA SYSTEM, MODEL 8850-0001 | OHV | Unknown | Ulthera, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 14, 2016 | 75682 | Class II | Terminated | Cellfina Prep Pack, Part No. CP1 | It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup. | accessdata.fda.gov |
| May 20, 2016 | 74252 | Class II | Terminated | Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and fol | Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle. | accessdata.fda.gov |
| October 26, 2015 | 72591 | Class II | Terminated | PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and | The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect. | accessdata.fda.gov |
| October 26, 2015 | 72585 | Class II | Terminated | Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds. | The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect. | accessdata.fda.gov |
Compare with other makers
- All makers of Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
Updated May 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.