Data / Medical devices / Slovenia / Fotona D.O.O.
Fotona D.O.O.: FDA-registered device maker in Ljubljana, Slovenia, 18 510(k) clearances
Fotona D.O.O. is registered with the FDA (registration 9613462) in Ljubljana, Slovenia. It lists 9 device types. The FDA files 18 510(k) clearances under its listings, the newest dated March 27, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9613462
- FEI number
- 1000597018
- Address
- Stegne 7, Ljubljana, Slovenia, 1000
- Owner or operator
- FOTONA D.O.O. (9032993)
- Roles
- Manufacturer
- First device listed
- October 10, 2011
- Registered through
- 2026
- Brand names listed
- AvalancheLase Family, Dynamis Pro Family, Fotona Dynamis, Fotona Lightwalker Laser System Family, Fotona XP Nd:YAG Laser System Family, Fotona XP Plus Nd:YAG Family, LightWalker Laser System Family, QuantumStar and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electromagnetic Stimulator, Pain Relief | QPL | 2 | Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Laser, Dental, Soft Tissue | NVK | 2 | Manufacturer | accessdata.fda.gov |
| Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | PDZ | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 27, 2025 | K241785 | StarFormer (M008-3T) | QPL | Substantially Equivalent | Fotona D.O.O. | accessdata.fda.gov |
| August 23, 2024 | K242202 | LightWalker Laser System Family | GEX | Substantially Equivalent | Fotona D.O.O. | accessdata.fda.gov |
| July 1, 2024 | K234061 | StarFormer | KPI | Substantially Equivalent | Fotona D.O.O. | accessdata.fda.gov |
| September 29, 2023 | K221274 | StarFormer, TightWave | IPF | Substantially Equivalent | Fotona D.O.O. | accessdata.fda.gov |
| January 19, 2023 | K223540 | AvalancheLase Family | GEX | Substantially Equivalent | Fotona D.O.O. | accessdata.fda.gov |
| September 8, 2022 | K213267 | Dynamis Pro Family | GEX | Substantially Equivalent | Fotona D.O.O. | accessdata.fda.gov |
| March 19, 2021 | K202985 | LightWalker Laser System Family | GEX | Substantially Equivalent | Fotona D.O.O. | accessdata.fda.gov |
| November 19, 2020 | K202172 | StarWalker | GEX | Substantially Equivalent | Fotona D.O.O. | accessdata.fda.gov |
| March 27, 2020 | K193656 | SkyPulse | GEX | Substantially Equivalent | Fotona D.O.O. | accessdata.fda.gov |
| March 25, 2020 | K193661 | LightWalker Laser System Family | GEX | Substantially Equivalent | Fotona D.O.O. | accessdata.fda.gov |
| August 30, 2019 | K191554 | LightWalker Laser System Family | GEX | Substantially Equivalent | Fotona D.O.O. | accessdata.fda.gov |
| October 31, 2018 | K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro | GEX | Substantially Equivalent | Fotona D.O.O. | accessdata.fda.gov |
| December 1, 2017 | K172819 | LightWalker Laser System Family | GEX | Substantially Equivalent | Fotona D.O.O. | accessdata.fda.gov |
| August 18, 2017 | K171227 | StarWalker | GEX | Substantially Equivalent | Fotona D.O.O. | accessdata.fda.gov |
| April 9, 2015 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | GEX | Substantially Equivalent | Fotona D.D. | accessdata.fda.gov |
| March 28, 2012 | K113702 | FOTONA XP ND: YAG LASER SYSTEM | PDZ | Substantially Equivalent | Fotona D.D. | accessdata.fda.gov |
| June 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, | GEX | Substantially Equivalent | Fotona D.D. | accessdata.fda.gov |
| March 18, 2005 | K050293 | FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS | GEX | Substantially Equivalent | Fotona D.D. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Stimulator, Electrical, Non-Implantable, For Incontinence
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Stimulator, Muscle, Powered
- All makers of Electromagnetic Stimulator, Pain Relief
- All makers of Laser, Dental, Soft Tissue
Updated March 27, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.