AR1000 ULTRASONIC WOUND THERAPY SYSTEM (K062544) - FDA 510(k) Clearance

K062544 is an FDA 510(k) clearance for the AR1000 ULTRASONIC WOUND THERAPY SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Arobella Medical, LLC (Carmel, US). The FDA issued a Cleared decision on January 3, 2007 after a review of 126 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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