510(k) Report

FDA applicant

Fotona D.D.

Ljubljana, SI27 decisions1998–20150 recalls

FDA records 27 decisions for Fotona D.D. (Ljubljana, SI) from 1998 to 2015: 27 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and PDZ (Lasers For Temporary Increase Of Clear Nail In…). Its devices cite 70 predicates, 31 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Fotona D.D.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2008: 12009: 32010: 22011: 12012: 22014: 12015: 1
2007high 3 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Fotona D.D. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fotona D.D.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument25decisions
  • PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis2decisions

Whose devices does it build on?

Its devices cite 70 predicates; 31 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 70 times; 31 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 20097cite it
  • K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models M021-4AF/3, M002-2AFotona D.D. · 20116cite it
  • K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model MOO1-14F, MOO1-14F…Fotona D.D. · 20096cite it
  • K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis, Powerlase at / Fidelis ER…Fotona D.D. · 20105cite it
  • K021548Fotona Dualis ND:Yag/ER:Yag Laser SystemFotona D.D. · 20025cite it
  • K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 20084cite it

What has FDA decided for it lately?

  • K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
  • K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
  • K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D. · 2012
  • K113702Fotona XP ND: Yag Laser SystemFotona D.D. · 2012
  • K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models M021-4AF/3, M002-2AFotona D.D. · 2011
  • K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E, Model M002-6A/2…Fotona D.D. · 2010
  • K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis, Powerlase at / Fidelis ER…Fotona D.D. · 2010
  • K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model MOO1-14F, MOO1-14F…Fotona D.D. · 2009

All 27 as Fotona D.D. →

Other applicant names beginning “Fotona”

FDA records each applicant name separately; these may or may not be the same firm.

Fotona D.O.O. 17