FDA 510(k) Applications Submitted by Kathy Maynor
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K140005 |
01/02/2014 |
ALMA DIODE TABLETOP LASER |
ALMA LASERS LTD. |
K140009 |
01/02/2014 |
SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM |
ALMA LASERS LTD. |
K190007 |
01/02/2019 |
Vydence Laser Family |
Vydence Medical Industria E Comercio Ltda |
K220041 |
01/05/2022 |
HandPICO |
Vydence Medical Industria E Comercio Ltda |
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. |
K130413 |
02/19/2013 |
PINPOINTE FOOTLASER |
NUVOLASE, 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. |
K121150 |
04/16/2012 |
ALMA LASERS FAMILY OF PIXEL RF TIPS |
ALMA LASERS INC. |
K141237 |
05/13/2014 |
HARMONY LITE |
ALMA INC. |
K171443 |
05/16/2017 |
Etherea MX |
Vydence Medical Industria E Comercio Ltda |
K131805 |
06/19/2013 |
INPULSE LASER |
INCISIVE INC. |
K022226 |
07/10/2002 |
ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS |
ALTUS MEDICAL, INC. |
K172096 |
07/11/2017 |
Fraxis |
Ilooda Co. LTD |
K092195 |
07/21/2009 |
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) |
CUTERA, INC. |
K042165 |
08/11/2004 |
CUTERA TABLETOP AESTHETIC PRODUCT |
CUTERA, INC. |
K162416 |
08/30/2016 |
IRIDEX Cyclo G6 Laser System, G-Probe Illuminate |
IRIDEX CORPORATION |
K202998 |
10/01/2020 |
Vydence Zye and Vydence One |
Vydence Medical Industria E Comercio Ltda |
K023954 |
11/27/2002 |
ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES |
ALTUS MEDICAL, INC. |
K033768 |
12/03/2003 |
ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE |
ALTUS MEDICAL, INC. |
K014040 |
12/07/2001 |
FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS |
ALTUS MEDICAL, INC. |
K991258 |
04/13/1999 |
NOVUS VERDI DELIVERY SYSTEMS |
LUMENIS, INC. |
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