Cleared Traditional

K062544 - AR1000 ULTRASONIC WOUND THERAPY SYSTEM

K062544 · Arobella Medical, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
126d
Days
-
Risk

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.

View all Arobella Medical, LLC devices

FDA 510(k) Submission Details - K062544

510(k) Number K062544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2006
Decision Date January 03, 2007
Days to Decision 126 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 115d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

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