# K050293: Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.D.
- Decided: Mar 18, 2005 after 39 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K910422 (1992). 96 ancestors in all.
200 later devices descend from it; 4 cite it directly.
0 of 297 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033172: Candela Gentleyag Family of Laser Systems, Candela Corp. (2003)
- K023954: Altus Medical Coolglide Laser Systems and Accessories, Altus Medical, Inc. (2003) Summary page 5.
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models, Altus Medical, Inc. (2002) Summary page 5.
- K022839: Fotona Dualis Plus ND:Yag Laser System, Fotona D.D. (2002). Our reading of the summary gave K002839, FDA’s number for End Expiratory Filter, Model RT020 (Fisher & Paykel Healthcare, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Fotona Dualis XP Plus”.

## Most influential descendants
- K070355: Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family (2008), 194 descendants of its own
- K083889: Fotona QX ND:Yag/KTP Laser System Family (2009), 166 descendants of its own
- K103455: Spectra Laser System (2011), 92 descendants of its own
- 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), 83 descendants of its own
- K113588: Spectra Laser System (2012), 82 descendants of its own

## Indications for use
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of I'FB. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, hernoangioma, warts, telangiectasia, rosacea, Venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Incision/excision of soft body tissue in dermatology Soft tissue general surgery applications-skin incision; tissue dissection; cornpelte or partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafd au lait macules, seborrheic keratosis, nevi, chloasma, vermcae, skin tags, keratosis, tattoos (significant reduction in the intensity of black andlor blue-black tatoos) and plaques. The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The laser is also indicated for the reduction of red pigmentation and hypertrophic and keloid scars where vascularity is an integral part of the scar. 'rrcatment of wrinkles.

Source page: https://510kreport.com/device/K050293
Methodology: https://510kreport.com/methodology