# K101817: Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E, Model M002-6A/2, Lightwalker ST-N

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.D.
- Decided: Nov 22, 2010 after 145 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). 107 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 3.

## Most influential descendants
- K130420: SOLEA (2013), 2 descendants of its own
- K151306: Solea (2015), 1 descendant of its own
- K121508: Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-N (2012), 1 descendant of its own
- K221761: Solea (2022), 0 descendants of its own
- 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 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 nmn wavelength) in dermatology and o ther surgical areas: - Dermatology and Plastic SueryM 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 Surger 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; - Podiatr Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy; Nd:YAG laser (1064 tim 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 trou-ghing 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 imflamned 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 inn 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

Source page: https://510kreport.com/device/K101817
Methodology: https://510kreport.com/methodology