SOUND VASER SYSTEM— 510(k) K991791

Name: FDA 510(k) clearance K991791
Creator: U.S. Food and Drug Administration
Published: 1999-08-12

Substantially Equivalent

Sound Surgical Technologies, LLC

FDA 510(k) clearance K991791 for SOUND VASER SYSTEM, Substantially Equivalent on 1999-08-12. Applicant: Sound Surgical Technologies, LLC. Device class: Unclassified.

Clearance details

Applicant: Sound Surgical Technologies, LLC
Product code: Code LFL
Device class: Unclassified
Advisory panel: Unknown
Date received: 1999-05-25
Decision date: 1999-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lafayette, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFL

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K261448 — neXus Ultrasonic Surgical Aspirator System2026-07-30
K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System2025-10-08
K242894 — SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10) +4 more2025-06-18
K243930 — Sonopet iQ Ultrasonic Aspirator System (5500-050-000)2025-03-24
K241700 — Tenex 2nd Generation System2024-11-18

More clearances from Sound Surgical Technologies, LLC

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K120328 — ORIGINS LIPOHARVESTING SYSTEM2012-09-17
K110306 — SOUND SURGICAL VASER 2.1 LIPO SYSTEM2011-06-23
K110255 — SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM2011-04-04
K022051 — SOUNDVASER SYSTEM2002-09-11
K993868 — THE SOUNDVASER DISSECTION SYSTEM1999-12-21

Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.