FDA 510(k) Applications Submitted by FOTONA D.D.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K991632 |
05/12/1999 |
FOTONA NOVALIS ER: YAG LASER SYSTEM |
FOTONA D.D. |
| K991634 |
05/12/1999 |
FOTONA NOVALIS R RUBY LASER SYSTEM |
FOTONA D.D. |
| K000106 |
01/13/2000 |
DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES |
FOTONA D.D. |
| K990243 |
01/25/1999 |
FOTONA FIDELIS ER:YAG LASER SYSTEM & ACCESSORIES |
FOTONA D.D. |
| K980560 |
02/13/1998 |
FOTONA SKINPLUS LASER SYSTEM |
FOTONA D.D. |
| K011174 |
04/17/2001 |
PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSORIES |
FOTONA D.D. |
| K021548 |
05/13/2002 |
FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM |
FOTONA D.D. |
| K001527 |
05/16/2000 |
FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES |
FOTONA D.D. |
| K011939 |
06/21/2001 |
FOTONA DUALIS, FOTONA DUALIS PLUS |
FOTONA D.D. |
| K022837 |
08/27/2002 |
FOTONA TANDEM LASER SYSTEM |
FOTONA D.D. |
| K022838 |
08/27/2002 |
FOTONA DUALIS ER:YAG/KTP LASER SYSTEM |
FOTONA D.D. |
| K022839 |
08/27/2002 |
FOTONA DUALIS PLUS ND:YAG LASER SYSTEM |
FOTONA D.D. |
| K002884 |
09/15/2000 |
PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES |
FOTONA D.D. |
| K024204 |
12/20/2002 |
FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM |
FOTONA D.D. |
| K121508 |
05/21/2012 |
LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N |
FOTONA D.D. |
| K090126 |
01/21/2009 |
FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2, |
FOTONA D.D. |
| K070355 |
02/06/2007 |
FOTONA FIDELIS III ER:YAG/ND:YAG LASER SYSTEM FAMILY |
FOTONA D.D. |
| K050293 |
02/07/2005 |
FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS |
FOTONA D.D. |
| K101306 |
05/10/2010 |
SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A |
FOTONA D.D. |
| K101817 |
06/30/2010 |
LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N |
FOTONA D.D. |
| K132806 |
09/06/2013 |
FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE |
FOTONA D.D. |
| K093162 |
10/06/2009 |
FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID |
FOTONA D.D. |
| K083034 |
10/10/2008 |
FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F |
FOTONA D.D. |
| K053139 |
11/09/2005 |
FOTONA QX ND:YAG/KTP LASER SYSTEM |
FOTONA D.D. |
| K113702 |
12/16/2011 |
FOTONA XP ND: YAG LASER SYSTEM |
FOTONA D.D. |
| K083889 |
12/29/2008 |
FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY |
FOTONA D.D. |
| K143723 |
12/29/2014 |
SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro |
FOTONA D.D. |
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