Lightwave Integrated Electrode Ablator and Light Wave Integrated Electrode Suction Ablator

• • Terminated Z-2051-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2009 ·on shared 510(k) K050923

  ConMed Linvatec has determined there is a possibility that the device may not shut off if the ablate button is released, which may result in users/patients suffering burns.

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

510(k) Number

K050923 ↗

FDA Product Code

JOS

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Conmed Linvatec →