# K172819: LightWalker Laser System Family

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.O.O.
- Decided: Dec 1, 2017 after 74 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). 108 ancestors in all.
20 later devices descend from it; 1 cites it directly.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070355: Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family, Fotona D.D. (2008) Summary page 6.
- K151763: PerioLase Nd:YAG Pulsed Dental Laser System, Millennium Dental Technologies, Inc. (2016) Summary page 6.

## Most influential descendants
- K191554: LightWalker Laser System Family (2019), 19 descendants of its own
- K193656: SkyPulse (2020), 11 descendants of its own
- K193661: LightWalker Laser System Family (2020), 8 descendants of its own
- K202985: LightWalker Laser System Family (2021), 7 descendants of its own
- K202991: Fotona XPulse Pro Laser Platform (2021), 3 descendants of its own

## Indications for use
Er:YAG laser (2940 nm wavelength) in dentistry: – Intra-oral soft tissue surgery (incision, excision, ablation coagulation) – Leukoplakia – Pulpotomy as adjunct to root canal retreatment – Pulp extirpation – Removal of fibromae – Removal of granulated tissue – Caries removal, cavity preparation, enamel roughening – Sulcular debridement – Tooth preparation to obtain access to root canal, root canal debridement and cleaning, root canal preparation including enlargement – Cutting, shaving, contouring and resection of oral osseous tissue (bone) – Osteotomy, osseous crown lengthening, osteoplasty – Apicectomy surgery – Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curetage Er:YAG laser (2940 nm wavelength) in dermatology and other surgical areas: – Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and skin resurfacing; – ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia; – Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectomy; – General Surgery Indications: Surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation; – Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy; – Ophtalmology Indications: Soft tissue surrounding the eye ; – Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma; Nd:YAG laser (1064 nm wavelength) in dentistry: – Excisional and incisional biopsies – Excision and vaporization of herpes simplex I and II – Exposure of unerupted teeth – Fibroma removal – Frenectomy and frenotomy – Gingival troughing for crown impressions – Gingivectomy – Gingivoplasty – Gingival incision and excision – Hemostasis – Implant recovery – Incision and drainage of abscess – Laser assisted uvulopaletoplasty (LAUP) – Operculectomy – Oral papillectomies – Pulpotomy and pulpotomy as an adjunct to root canal therapy – Reduction of denture hyperplasia – Reduction of gingival hypertrophy – Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy – Removal of post-surgical granulations – Soft tissue crown lengthening – Sulcular debridement or soft tissue curettage (removal of diseased or imflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility) – Tissue retraction for impression – Treatment of aphtous ulcers – Vestibuloplasty Nd:YAG laser (1064 nm wavelength) in dermatology and other surgical areas: – 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 – Treatment of wrinkles – Treatment of mild to moderate inflammatory acne vulgaris – General surgery indications: surgical incision, excision, vaporization and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartillage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal. – Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: – Matrixectomy – Periungual and subungual warts – Plantar warts – Radical nail excision – Neuromas The Fotona LightWalker Laser System Family is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).

Source page: https://510kreport.com/device/K172819
Methodology: https://510kreport.com/methodology