# K083889: Fotona QX ND:Yag/KTP Laser System Family

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.D.
- Decided: Apr 23, 2009 after 115 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: 10 generations back to K910422 (1992). 124 ancestors in all.
166 later devices descend from it; 7 cite it directly.
0 of 291 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053139: Fotona QX ND:Yag/KTP Laser System, Fotona D.D. (2006) Summary page 2.
- K063834: Revlite C6 Q-Switched ND:Yag Laser System, Hoya Conbio, Inc. (2007) Summary page 2.
- K033172: Candela Gentleyag Family of Laser Systems, Candela Corp. (2003) Summary page 2.
- K070355: Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family, Fotona D.D. (2008) Summary page 3.
- K040131: Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser System, New Star Lasers, Inc. (2004) Summary page 3.
- K041086: Palomar Starlux Pulsed Light System, Palomar Medical Products, Inc. (2005) Summary page 3.

## Most influential descendants
- 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
- K143105: Picosure Workstation (2015), 49 descendants of its own

## Indications for use
The Fotona QX Nd:YAG/KTP Laser System Family is indicated for incision, excision, ablation and vaporization of soft tissue for general dermatology. Specific Indications: 1064 nm wavelength in Q-switched mode: - Removal of dark ink (black, blue and brown) tattoos - Treatment of nevus of Ota - Treatment of common nevi - Removal or lightening of unwanted hair - Skin resurfacing procedures for the treatement of acne scars and wrinkles 1064 nm wavelength in non- Q-switched mode: - Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for 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, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins - Coagulation and hemostasis of soft tissue - Treatment of wrinkles - Treatment of mild to moderate inflammatory acne vulgaris 532 un wavelength in Q-switched mode (nominal delivered energy of 585 nm and 650 nm with the optional 585 nm and 650 nm dye converter handpieces): - Removal of light ink (red, sky blue, green, tan, purple, and orange) tatoos - Treatment of vascular lesions including, but not limited to: - port wine birthmarks - telangiectasias - spider angiomaa - Treatment of pigmented lesions including, but not limited to: - cafe-au-Iait birthmarks - solar lentigines - senile lentigines - Becker's nevi - freckles - common nevi - nevus spilus - Treatment of seborrheic keratosis - Treatment of post inflammatory hyperpigmentation - Skin resurfacing procedures for the treatment of acne scars and wrinkles.

Source page: https://510kreport.com/device/K083889
Methodology: https://510kreport.com/methodology