# K202172: StarWalker

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.O.O.
- Decided: Nov 19, 2020 after 108 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: 26 generations back to K943450 (1995). 566 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 570 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171227: StarWalker, Fotona D.O.O. (2017) Summary page 5.
- 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.
- K191685: PicoWay Laser System, Candela Corporation (2019) Summary page 5.
- K173199: PicoSure Workstation, Cynosure, Inc. (2018) Summary page 5.
- K113588: Spectra Laser System, Lutronic Corporation (2012) Summary page 5.

## Most influential descendants
- K253342: PICO-K (2025), 1 descendant of its own
- K261214: Pico Shining (Pico-K; Picofy) (2026), 0 descendants of its own
- K253344: Bellus-Q (2025), 0 descendants of its own

## Indications for use
The StarWalker Laser System Family is indicated 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 -Treatment of melasma -General dermatology indications: Incision, excision, ablation and vaporization of soft tissue 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 -Removal of epidermal pigmented lesions 532 nm wavelength in long pulse mode: -Incision, ablation vaporization, coagulation and hemostasis of vascular lesions and soft tissue in various surgical areas. All soft tissue is included, such as skin, cutaneous tissue, subcutaneoous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. -The treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size) of the benign vascular lesions (Angiomas, Hemangiomas, Telangiectasia) 1064 nm wavelength in PICO mode: -Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple -Benign pigmented lesions removal for Fitzpatrick Skin Types I-IV -Treatment of acne scars in Fitzpatrick Skin Types II‐V -Treatment of wrinkles as well as benign pigmented lesions in Fitzpatrick Skin Types I‐IV 532 nm wavelength in PICO mode: -Tattoo removal in Skin Types I - III -Treatment of benign pigmented lesions in Fitzpatrick Skin Types I‐IV

Source page: https://510kreport.com/device/K202172
Methodology: https://510kreport.com/methodology