Definition: The Ultrasound Wound Cleaner/mild Debridement System Is A Device That Delivers A Cleaning Fluid To The Wound That Is Pulsed Using Low Power Ultrasound Radiation. The Device Is Intended To Clean And Mildly Debride Wounds. The Ultrasound Generator Must
| Device Type ID | 5780 |
| Device Name | Wound Cleaner, Ultrasound |
| Regulation Description | Low Energy Ultrasound Wound Cleaner. |
| 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 One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4410 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NRB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
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| Device Type ID | 5780 |
| Device | Wound Cleaner, Ultrasound |
| Product Code | NRB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Low Energy Ultrasound Wound Cleaner. |
| CFR Regulation Number | 878.4410 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALLIQUA BIOMEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AROBELLA MEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CELLERATION, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |