# K191554: LightWalker Laser System Family

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.O.O.
- Decided: Aug 30, 2019 after 79 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: 11 generations back to K910422 (1992). 111 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172819: LightWalker Laser System Family, Fotona D.O.O. (2017) Summary page 6.
- K141861: Hilthera 4.0, Jeisys Medical, Inc. (2015) Summary page 6.

## Most influential descendants
- 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
- K240179: Medical Diode Laser (Model: L2) (2024), 2 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 [ 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 inflamed 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 » Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium) » Periodontal regeneration — true regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface 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-V1, including tanned skin* * Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemangiomae, 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. » Temporary increase of clear nail in patients with onychomycosis (e.g. dermatophytes Trichophyton rubrum and T mentagrophytes and/or yeasts Candida albicans, etc.) Nd:YAG laser (1064 nm wavelength) therapy: » Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle. *Note: Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Source page: https://510kreport.com/device/K191554
Methodology: https://510kreport.com/methodology