# K113702: Fotona XP ND: Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.D.
- Decided: Mar 28, 2012 after 103 days
- Product code: PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis)
- 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: 9 generations back to K936109 (1994). 112 ancestors in all.
65 later devices descend from it; 2 cite it directly.
0 of 178 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103626: Cutera Genesisplus Laser System, Cutera, Inc. (2011) Summary page 2.
- K093547: Pinpointe Footlaser, Pinpointe USA, Inc. (2010) Summary page 2.

## Most influential descendants
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own
- K153671: Family of CoolGlide Aesthetic Lasers (2016), 32 descendants of its own
- K170626: Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece (2017), 24 descendants of its own
- K172193: Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules (2018), 22 descendants of its own
- K182088: XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro (2018), 20 descendants of its own

## Indications for use
Fotona XP Nd:YAG Laser System Family is indicated for podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: - Matrixectomy - Radical nail excision - Periungual and subungual warts - Plantar warts - Neuromas - Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Teichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)

Source page: https://510kreport.com/device/K113702
Methodology: https://510kreport.com/methodology