Company ยท SI
Fotona D.D.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2015. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 9, 2015 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro Fotona D.D., SI | GEX |
| Jul 11, 2014 | K132806 | FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE Fotona D.D., SI | GEX |
| Dec 12, 2012 | K121508 | LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N Fotona D.D., SI | PDZ |
| Mar 28, 2012 | K113702 | FOTONA XP ND: YAG LASER SYSTEM Fotona D.D., SI | PDZ |
| Jul 1, 2011 | K101306 | SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A Fotona D.D., SI | GEX |
| Nov 22, 2010 | K101817 | 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., SI | GEX |
| Jan 22, 2010 | K093162 | 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., SI | GEX |
| Jun 29, 2009 | K090126 | 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., SI | GEX |
| Apr 23, 2009 | K083889 | FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY Fotona D.D., SI | GEX |
| Feb 4, 2009 | K083034 | FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F Fotona D.D., SI | GEX |
| Mar 4, 2008 | K070355 | FOTONA FIDELIS III ER:YAG/ND:YAG LASER SYSTEM FAMILY Fotona D.D., SI | GEX |
| Feb 16, 2006 | K053139 | FOTONA QX ND:YAG/KTP LASER SYSTEM Fotona D.D., SI | GEX |
| Mar 18, 2005 | K050293 | FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS Fotona D.D., SI | GEX |
| Jul 7, 2003 | K024204 | FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM Fotona D.D., SI | GEX |
| Dec 6, 2002 | K021548 | FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM Fotona D.D., SI | GEX |
| Nov 25, 2002 | K022839 | FOTONA DUALIS PLUS ND:YAG LASER SYSTEM Fotona D.D., SI | GEX |
| Nov 25, 2002 | K022838 | FOTONA DUALIS ER:YAG/KTP LASER SYSTEM Fotona D.D., SI | GEX |
| Nov 25, 2002 | K022837 | FOTONA TANDEM LASER SYSTEM Fotona D.D., SI | GEX |
| Dec 27, 2001 | K011939 | FOTONA DUALIS, FOTONA DUALIS PLUS Fotona D.D., SI | GEX |
| Nov 7, 2001 | K011174 | PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSORIES Fotona D.D., SI | GEX |
| Dec 4, 2000 | K002884 | PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES Fotona D.D., SI | GEX |
| Jul 27, 2000 | K001527 | FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES Fotona D.D., SI | GEX |
| Apr 18, 2000 | K000106 | DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES Fotona D.D., SI | GEX |
| Aug 10, 1999 | K991634 | FOTONA NOVALIS R RUBY LASER SYSTEM Fotona D.D., SI | GEX |
| Aug 10, 1999 | K991632 | FOTONA NOVALIS ER: YAG LASER SYSTEM Fotona D.D., SI | GEX |
| Jun 9, 1999 | K990243 | FOTONA FIDELIS ER:YAG LASER SYSTEM & ACCESSORIES Fotona D.D., SI | GEX |
| Mar 27, 1998 | K980560 | FOTONA SKINPLUS LASER SYSTEM Fotona D.D., SI | GEX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||