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Auriga Xl

by Starmedtec GmbH

510(k) K111475

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

14 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 NumberK111475 Date28 Sep 2011ClearedStatusActive

Recalls

14 recalls · FDA

  • 9 recalls, same reason

    • Terminated Z-1398-2019 FDA Class II initiated 8 Apr 2019
    • Terminated Z-1392-2019 FDA Class II initiated 8 Apr 2019
    • Terminated Z-1397-2019 FDA Class II initiated 8 Apr 2019
    • Terminated Z-1394-2019 FDA Class II initiated 8 Apr 2019
    • Terminated Z-1399-2019 FDA Class II initiated 8 Apr 2019
    • Terminated Z-1395-2019 FDA Class II initiated 8 Apr 2019
    • Terminated Z-1393-2019 FDA Class II initiated 8 Apr 2019
    • Terminated Z-1396-2019 FDA Class II initiated 8 Apr 2019
    • Terminated Z-1391-2019 FDA Class II initiated 8 Apr 2019

    Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.

  • 2 recalls, same reason

    • Terminated Z-0898-2018 FDA Class II initiated 22 Sep 2017
    • Terminated Z-0897-2018 FDA Class II initiated 22 Sep 2017

    Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console.

  • 3 recalls, same reason

    • Terminated Z-0049-2015 FDA Class II initiated 30 Sep 2014
    • Terminated Z-0051-2015 FDA Class II initiated 30 Sep 2014
    • Terminated Z-0050-2015 FDA Class II initiated 30 Sep 2014

    Product is not cleared for use with lasers other than the Auriga XL system

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  • Withdrawn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
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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