# Fotona D.O.O.

- Location (FDA's records): Ljubljana, SI
- FDA decisions: 17 (2017–2026): 17 510(k) clearances
- Product codes: GEX (14), QPL (1), KPI (1), IPF (1)
- 510(k) review time since 2016: median 114 days, against 90 for FDA's reviews in the same codes and years (7 of 17 faster)
- Predicates its devices cite: 56 (18 its own); citations of its devices by later devices: 29 (18 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Fotona D.D.: 9 (https://510kreport.com/company/fotona-dd)
- Candela Corp.: 3 (https://510kreport.com/company/candela)
- Biolase, Inc.: 3 (https://510kreport.com/company/biolase)
- A.R.C Laser GmbH: 3 (https://510kreport.com/company/arc-laser)
- Neotonus, Inc.: 2 (https://510kreport.com/company/neotonus)
- G.N.S Neolaser, Ltd.: 2 (https://510kreport.com/company/gns-neolaser)
- Dentsply Sirona: 2 (https://510kreport.com/company/dentsply-sirona)
- Cynosure, Inc.: 1 (https://510kreport.com/company/cynosure)

## Firms that cite its devices most
- Wuhan Pioon Technology Co., Ltd.: 2 (https://510kreport.com/company/wuhan-pioon-technology)
- Speclipse, Inc.: 2 (https://510kreport.com/company/speclipse)
- Sciton, Inc: 1 (https://510kreport.com/company/sciton)
- Gigaalaser Company, Ltd.: 1 (https://510kreport.com/company/gigaalaser)
- A.R.C Laser GmbH: 1 (https://510kreport.com/company/arc-laser)
- SNJ Co., Ltd.: 1 (https://510kreport.com/company/snj)
- Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd: 1 (https://510kreport.com/company/shanghai-wonderful-opto-electrics-tech)
- Reveal Lasers, Ltd.: 1 (https://510kreport.com/company/reveal-lasers)

## Its most-cited devices
- K193656: SkyPulse (2020), cited by 6
- K182088: XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro (2018), cited by 5
- K202985: LightWalker Laser System Family (2021), cited by 3
- K202172: StarWalker (2020), cited by 2
- K171227: StarWalker (2017), cited by 2
- K213267: Dynamis Pro Family (2022), cited by 2

## Recent decisions
- K252723: Dynamis Pro Family (Sep 19, 2026)
- K241785: StarFormer (M008-3T) (Mar 27, 2025)
- K242202: LightWalker Laser System Family (Aug 23, 2024)
- K234061: StarFormer (Jul 1, 2024)
- K221274: StarFormer, TightWave (Sep 29, 2023)
- K223540: AvalancheLase Family (Jan 19, 2023)
- K221712: Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) (Oct 12, 2022)
- K213267: Dynamis Pro Family (Sep 8, 2022)

Source page: https://510kreport.com/company/fotona-doo