Cleared Traditional

THE SOUNDVASER DISSECTION SYSTEM (K993868) - FDA 510(k) Clearance

K993868 · Sound Surgical Technologies, LLC · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 1999
Decision
36d
Days
-
Risk

K993868 is an FDA 510(k) clearance for the THE SOUNDVASER DISSECTION SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Sound Surgical Technologies, LLC (Lafayette, US). The FDA issued a Cleared decision on December 21, 1999 after a review of 36 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 Sound Surgical Technologies, LLC devices

Submission Details

510(k) Number K993868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1999
Decision Date December 21, 1999
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

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