K950945 - COOPER LASER SONICS CUSA MODEL 200 (FDA 510(k) Clearance)

K950945 is an FDA 510(k) clearance for the COOPER LASER SONICS CUSA MODEL 200. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Valleylab, Inc. (Boulder, US). The FDA issued a Cleared decision on April 10, 1995 after a review of 82 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Valleylab, Inc. devices