We regret to inform you that your certification is incomplete, and therefore inadequate, as submitted. Your certification states that “the computer hardware, firmware and software in my laser allow it to perform all the procedures of the PMA approved device in an identical manner. ” A certification must establish that the limitations of operation required under the approved premarket approval (PMA) apply to your laser. Your submission does not adequately address the restrictions required under the PMA relating to the clinical capabilities of the laser; you have not stated that your device is enabled only for those indications and conditions for which the model received PMA approval.
