# Fotona D.D.

- Location (FDA's records): Ljubljana, SI
- FDA decisions: 27 (1998–2015): 27 510(k) clearances
- Product codes: GEX (25), PDZ (2)
- Predicates its devices cite: 70 (31 its own); citations of its devices by later devices: 70 (31 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
- New Star Lasers, Inc.: 5 (https://510kreport.com/company/new-star-lasers)
- Laserscope: 5 (https://510kreport.com/company/laserscope)
- Hoya Conbio, Inc.: 3 (https://510kreport.com/company/hoya-conbio)
- Candela Corp.: 3 (https://510kreport.com/company/candela)
- Millennium Dental Technologies, Inc.: 2 (https://510kreport.com/company/millennium-dental-technologies)
- Altus Medical, Inc.: 2 (https://510kreport.com/company/altus-medical)
- Cutera, Inc.: 2 (https://510kreport.com/company/cutera)
- Pinpointe USA, Inc.: 2 (https://510kreport.com/company/pinpointe-usa)

## Firms that cite its devices most
- Fotona D.O.O.: 9 (https://510kreport.com/company/fotona-doo)
- Biolase Technology, Inc.: 3 (https://510kreport.com/company/biolase-technology)
- Asclepion Laser Technologies GmbH: 3 (https://510kreport.com/company/asclepion-laser-technologies)
- Laseroptek Co., Ltd.: 3 (https://510kreport.com/company/laseroptek)
- Convergent Dental, Inc.: 2 (https://510kreport.com/company/convergent-dental)
- Lutronic Corporation: 2 (https://510kreport.com/company/lutronic)
- Depilase Group, Ltd.: 2 (https://510kreport.com/company/depilase-group)
- SNJ Co., Ltd.: 2 (https://510kreport.com/company/snj)

## Its most-cited devices
- K083889: Fotona QX ND:Yag/KTP Laser System Family (2009), cited by 7
- K101306: SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models M021-4AF/3, M002-2A (2011), cited by 6
- K090126: Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model MOO1-14F, MOO1-14F, MOO1-14F/2, (2009), cited by 6
- K093162: Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis, Powerlase at / Fidelis ER Iii D, HT Fid (2010), cited by 5
- K021548: Fotona Dualis ND:Yag/ER:Yag Laser System (2002), cited by 5
- K070355: Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family (2008), cited by 4

## Recent decisions
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (Apr 9, 2015)
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (Jul 11, 2014)
- K121508: Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-N (Dec 12, 2012)
- K113702: Fotona XP ND: Yag Laser System (Mar 28, 2012)
- K101306: SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models M021-4AF/3, M002-2A (Jul 1, 2011)
- K101817: Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E, Model M002-6A/2, Lightwalker ST-N (Nov 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 (Jan 22, 2010)
- K090126: Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model MOO1-14F, MOO1-14F, MOO1-14F/2, (Jun 29, 2009)

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