SOUND VASER SYSTEM— 510(k) K991791

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.

Clearance details

Applicant: Sound Surgical Technologies, LLC
Product code: Code LFL
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 ↗

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.