510(k) submissions4 totalK numberDevice nameProduct codeClassDecision dateK221789IRIS Pi Q switched Nd YAG laserGEXClass 22022-08-09K212082PicoreGEXClass 22021-10-06K182270Cellene CO2 Laser SystemGEXClass 22018-11-02K163638Dental 5 Multi Diode laserGEXClass 22017-05-15