# K171227: StarWalker

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.O.O.
- Decided: Aug 18, 2017 after 114 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: 21 generations back to K943450 (1995). 541 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 549 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083889: Fotona QX ND:Yag/KTP Laser System Family, Fotona D.D. (2009) Summary page 5.
- K011939: Fotona Dualis, Fotona Dualis Plus, Fotona D.D. (2001) Summary page 5.
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro, Fotona D.D. (2015) Summary page 5.

## Most influential descendants
- K202172: StarWalker (2020), 3 descendants of its own
- K202288: Finebeam (2021), 2 descendants of its own
- K253342: PICO-K (2025), 1 descendant of its own
- K261214: Pico Shining (Pico-K; Picofy) (2026), 0 descendants of its own
- K260256: Q-Switched Nd: YAG Laser Systems (2026), 0 descendants of its own

## Indications for use
The Fotona StarWalker Laser System Family, and its accessories, are intended for: 1064 nm wavelength in Q-switched mode: – Removal of dark (black, blue, brown) tattoo ink – Treatment of nevus of ota – Treatment of common nevi – Removal and lightening of unwanted hair – Skin resurfacing procedures for the treatment of acne scars and wrinkles 1064 nm wavelength in long pulse 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 benign pigmented and benign 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 nm 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): – Red, tan, purple and orange tattoo ink removal – Sky blue (light) tattoo ink removal – Green tattoo tattoo ink removal – Treatment of benign pigmented lesions including, but not limited to: – cafe-au-lait birthmarks – solar lentigines – senile lentigines – senile lentigines – Becker's nevi – freckles – common nevi – nevus spilus – Treatment of benign vascular lesion including, but not limited to: – port wine birthmarks – telangiectasias – spider angioma – cherry angioma – spider nevi – Seborrheic Keratosis – Treatment of post-inflammatory hyperpigmentation – Skin resurfacing procedures for the treatment of acne scars and wrinkles 532 nm wavelength in long pulse mode: – The treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size) of the benign vascular lesions (Angiomas, Hemangiomas, Telangiectasia)

Source page: https://510kreport.com/device/K171227
Methodology: https://510kreport.com/methodology