# K121508: Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-N

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.D.
- Decided: Dec 12, 2012 after 205 days
- Product code: PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis)
- 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: 12 generations back to K943450 (1995). 185 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 187 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101817: Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E, Model M002-6A/2, Lightwalker ST-N, Fotona D.D. (2010) Summary page 4.
- K093162: Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis, Powerlase at / Fidelis ER Iii D, HT Fid, Fotona D.D. (2010) Summary page 4.
- K101306: SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models M021-4AF/3, M002-2A, Fotona D.D. (2011) Summary page 4.
- K090126: Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model MOO1-14F, MOO1-14F, MOO1-14F/2,, Fotona D.D. (2009) Summary page 4.
- K113702: Fotona XP ND: Yag Laser System, Fotona D.D. (2012) Summary page 4.
- K103626: Cutera Genesisplus Laser System, Cutera, Inc. (2011) Summary page 5.
- K093547: Pinpointe Footlaser, Pinpointe USA, Inc. (2010) Summary page 5.

## Most influential descendants
- K182930: PerioLase Nd:YAG Pulsed Dental Laser System (2019), 0 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 cleamng, root canal preparation including enlargement Cutting, shaving, contouring and resection of oral osseous tissue (bone) Osleotomy, osseous crown lengthening, osleoplasty Apicectomy surgery Removal of subgingival calculi in pcnodomal 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, hyperkerat051s 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 intcrnal organs, lesions, tissue ablation and vessel coagulation; Podiatry Indications: Warts, plantar verrucac, large mosaic verrucae, matrixectomy; Ophthalmology Indications: Soft tissue surrounding the eye; Gynecology Indications; Herpes simplex, endometrial adhesion, CIN (Cerv:cal mtraepnhehal neoplasia), cysts, condiloma; Nd:YAG laser (1064 nm wavelength) in dentistry: Excisional and incisional biopsies Excision and vaporization of herpes simplex Iand 11 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 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. 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. Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasia, 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 sofl 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: Matrixcctomy Periungual and subungual warts Plantar warts Radical nail cxcision Neuromas The Fotc;na 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 mentagrophyies, and/or yeasts Candida albicans, eic.).

Source page: https://510kreport.com/device/K121508
Methodology: https://510kreport.com/methodology