K063531 - SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM (FDA 510(k) Clearance)

K063531 is an FDA 510(k) clearance for the SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Sra Developments, Ltd. (Ashburton, Devon, GB). The FDA issued a Cleared decision on February 22, 2007 after a review of 92 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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