# K053139: Fotona QX ND:Yag/KTP Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.D.
- Decided: Feb 16, 2006 after 99 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: 2 generations back to K971207 (1998). 4 ancestors in all.
168 later devices descend from it; 2 cite it directly.
0 of 173 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000317: Spectra-VRM Q-Switched ND:Yag Laser System, Spectra-VRM, Tissue Medical Lasers, Inc. (2000) Summary page 2.
- K014234: Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag Laser, Continuum Electro-Optics, Inc. (2002) Summary page 2.
- K023967: Palomar Q-Yag ND:Yag Laser System, Palomar Medical Technologies, Inc. (2003) Summary page 2.

## Most influential descendants
- 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
- K113588: Spectra Laser System (2012), 82 descendants of its own
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own
- K133254: Revlite Q-Switched ND:Yag Laser System (2014), 57 descendants of its own

## Indications for use
1. Incision, excision, ablation, vaporization of soft tissue for general dermatology. 2. 532 nm wavelength: - removal of light ink (red, tan, purple, and orange) tatoosf- - removal of pigmented lesions, removal of vascular lesions, - treatment of Lentigines, treatment of Cafe-Au-Lait, - treatment of Common Nevi, - treatment of Seborrheic Kearotoses, - treatment of Post Inflammatory Hyperpigmentation. 3. 1064 nm wavelength: - removal of dark ink (black, blue and brown) tattoos, - treatment of Nevus of Ota, - removal or lightening of unwanted hair, - treatment of Common Nevi. - skin resurfacing with or without adjuvant preparation

Source page: https://510kreport.com/device/K053139
Methodology: https://510kreport.com/methodology