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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