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Soundvaser System

by Sound Surgical Technologies, LLC

510(k) K022051

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK022051 Date11 Sep 2002ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0939-2011 FDA Unclassified (pre-2012) initiated 21 Dec 2010 on shared 510(k) K022051

    Surgical equipment, activated by a wireless foot switch, may remain powered on when switch is no longer depressed.

    • Terminated Z-0933-2008 FDA Unclassified (pre-2012) initiated 28 Dec 2007 on shared 510(k) K022051

    Failure to shut-off: Surgical equipment, activated by a wireless foot switch with VASER system, may remain powered on when switch is no longer depressed.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
QPB
Device Class
Class II
Regulation
21 CFR Part 878.5040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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