FDA 510(k) Applications Submitted by CUTERA, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K230660 03/10/2023 AviClear Laser System Cutera, Inc.
K213461 10/27/2021 AviClear Laser System Cutera, Inc.
K180709 03/19/2018 truSculpt RF Device; truSculpt; truSculpt 3D Cutera, Inc.
K160488 02/22/2016 Cutera enlighten III Laser System Cutera, Inc.
K140727 03/24/2014 CUTERA PICOSECOND LASER SYSTEM CUTERA, INC.
K170936 03/30/2017 Cutera enlighten III Laser System Cutera, Inc.
K172004 07/03/2017 truSculpt Cutera, Inc.
K172077 07/10/2017 Cutera enlighten III Laser System Cutera, Inc.
K162512 09/08/2016 truSculpt CUTERA, INC.
K133739 12/09/2013 TRUSCULPT CUTERA, INC.
K133945 12/23/2013 CUTERA PICOSECOND LASER SYSTEM CUTERA, INC.
K070138 01/16/2007 CUTERA ER:YAG LASER HANDPIECE CUTERA, INC.
K122389 08/07/2012 TRUSCULPT CUTERA, INC.
K122493 08/16/2012 GENESISPLUS CUTERA, INC.
K102954 10/05/2010 CUTERA QSWITCH LASER SYSTEM CUTERA, INC.
K103626 12/10/2010 CUTERA GENESISPLUS LASER SYSTEM CUTERA, INC.
K063867 12/29/2006 CUTERA ER:YSGG LASER HANDPIECE CUTERA, INC.
K182997 10/30/2018 enlighten III Laser System Cutera, Inc.
K153671 12/21/2015 Family of CoolGlide Aesthetic Lasers CUTERA, INC.
K050047 01/10/2005 CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY CUTERA, INC.
K050069 01/12/2005 CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT CUTERA, INC.
K080300 02/05/2008 CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) CUTERA, INC.
K080530 02/26/2008 MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE CUTERA, INC.
K050679 03/16/2005 CUTERA SOLERA OPUS AESTHETIC PRODUCT CUTERA, INC.
K092195 07/21/2009 CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) CUTERA, INC.
K042165 08/11/2004 CUTERA TABLETOP AESTHETIC PRODUCT CUTERA, INC.
K132185 07/15/2013 FAMILY OF COOLGLIDE AESTHETIC LASERS CUTERA, INC.


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