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 A
| Device Type ID | 5801 |
| Device Name | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
| Physical State | Ultrasound |
| Technical Method | Use Of Focused Ultrasound |
| Target Area | Soft Tissue |
| Regulation Description | Focused Ultrasound Stimulator System For Aesthetic Use. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4590 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OHV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5801 |
| Device | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
| Product Code | OHV |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Focused Ultrasound Stimulator System For Aesthetic Use. |
| CFR Regulation Number | 878.4590 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SYNERON | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
SYNERON MEDICAL LTD. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
ULTHERA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 57 |
Insufficient Information | 6 |
Improper Or Incorrect Procedure Or Method | 2 |
Device Operational Issue | 1 |
Off-Label Use | 1 |
| Total Device Problems | 67 |