Cleared Traditional

K853143 - COOPER LASER SONICS CUSA MODEL 200 (FDA 510(k) Clearance)

K853143 · Cooper Lasersonics, Inc. · Neurology device
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Oct 1985
Decision
79d
Days
-
Risk

K853143 is an FDA 510(k) clearance for the COOPER LASER SONICS CUSA MODEL 200. Classified as Neurosurgical Ultrasonic Instruments (product code LBK).

Submitted by Cooper Lasersonics, Inc. (Santa Clara, US). The FDA issued a Cleared decision on October 16, 1985 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Neurology 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 Cooper Lasersonics, Inc. devices

Submission Details

510(k) Number K853143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1985
Decision Date October 16, 1985
Days to Decision 79 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 148d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LBK Neurosurgical Ultrasonic Instruments
Device Class -