K243035 is an FDA 510(k) clearance for the Ulthera® System. This device is classified as a Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption (Class II - Special Controls, product code OHV).
Submitted by Ulthera, Inc. (Raleigh, US). The FDA issued a Cleared decision on February 24, 2025, 150 days after receiving the submission on September 27, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4590. A Device Using Focused Ultrasound To Produce Localized, Mechanical Motion Within Tissues And Cells For The Purpose Of Producing Either Localized Heating For Tissue Coagulation Or For Mechanical Cellular Membrane Disruption Intended For Non-invasive Aesthetic Use..
| 510(k) Number | K243035 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2024 |
| Decision Date | February 24, 2025 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OHV - Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4590 |
| Definition | A Device Using Focused Ultrasound To Produce Localized, Mechanical Motion Within Tissues And Cells For The Purpose Of Producing Either Localized Heating For Tissue Coagulation Or For Mechanical Cellular Membrane Disruption Intended For Non-invasive Aesthetic Use. |