510(k) Report

FDA applicant

Fotona D.O.O.

Ljubljana, SI17 decisions2017–20260 recalls

FDA records 17 decisions for Fotona D.O.O. (Ljubljana, SI) from 2017 to 2026: 17 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and QPL (Electromagnetic Stimulator, Pain Relief). Since 2016 its 510(k)s took a median of 114 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 56 predicates, 18 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.O.O.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2017: 22018: 12019: 12020: 32021: 22022: 22023: 22024: 22025: 12026 (partial year): 1
2017high 3 (2020) · low 1 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Fotona D.O.O. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fotona D.O.O.’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 Instrument14decisions
  • QPLElectromagnetic Stimulator, Pain Relief1decision
  • KPIStimulator, Electrical, Non-Implantable, For Incontinence1decision
  • IPFStimulator, Muscle, Powered1decision

How long do its 510(k) reviews take?

Since 2016, its 17 510(k)s took a median of 114 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 7 of its 17 were faster than that.

Whose devices does it build on?

Its devices cite 56 predicates; 18 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 29 times; 18 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.

  • K193656SkyPulseFotona D.O.O. · 20206cite it
  • K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O. · 20185cite it
  • K202985LightWalker Laser System FamilyFotona D.O.O. · 20213cite it
  • K202172StarWalkerFotona D.O.O. · 20202cite it
  • K171227StarWalkerFotona D.O.O. · 20172cite it
  • K213267Dynamis Pro FamilyFotona D.O.O. · 20222cite it

What has FDA decided for it lately?

  • K252723Dynamis Pro FamilyFotona D.O.O. · 2026
  • K241785StarFormer (M008-3T)Fotona D.O.O. · 2025
  • K242202LightWalker Laser System FamilyFotona D.O.O. · 2024
  • K234061StarFormerFotona D.O.O. · 2024
  • K221274StarFormer, TightWaveFotona D.O.O. · 2023
  • K223540AvalancheLase FamilyFotona D.O.O. · 2023
  • K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O. · 2022
  • K213267Dynamis Pro FamilyFotona D.O.O. · 2022

All 17 as Fotona D.O.O. →

Other applicant names beginning “Fotona”

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

Fotona D.D. 27