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Wound Cleaner, Ultrasound

Wound Cleaner, Ultrasound is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Wound Cleaner, Ultrasound
General, Plastic Surgery Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

NRB

View Product Code Classification

Class 2

21 CFR 878.4410

View CFR Regulation

General, Plastic Surgery

Device Characteristics

No

No

No

Eligible

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 deliver 1.0 mw/cm2 or less energy to the wound