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Sound Surgical Vaser 2.1 Lipo System

by Sound Surgical Technologies, LLC

510(k) K110306

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK110306 Date23 Jun 2011ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-3047-2017 FDA Class II initiated 1 Jun 2017 on shared 510(k) K110306

    Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. This only impacts units serviced between the dates of 09/08/2016 and 05/23/2017.

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  • Withdrawn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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