LightWalker Laser System Family

Fotona D.O.O.

Country / region:Slovenia (SI)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Slovenia (SI)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

3

Device details

FDA 510(k) registration fields

K number
K202985
Device name
LightWalker Laser System Family
Country / region
Slovenia(SI)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2020-09-30
Decision date
2021-03-19
Submission type
Traditional
Technology type
Er:YAG(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

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 curettage;

¢ Laser removal of porcelain and ceramic crowns and veneers;

¢ Flap preparation — incision of soft-tissue to prepare a flap and expose the bone;

¢ Cutting bone to prepare a window access to the apex (apices) of the root(s);

¢ Root-end preparation for retrofill amalgam or composite;

¢ Full thickness flap;

¢ Partial thickness flap;

¢ Split thickness flap;

¢ Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket;

¢ Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium;

¢ Excisional and incisional biopsies;

¢ Flap preparation — incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions);

¢ Frenectomy and frenotomy;

¢ Gingival troughing for crown impressions;

¢ Gingivectomy;

¢ Gingivoplasty;

¢ Implant recovery;

¢ Root canal debridement and cleaning;

¢ Soft tissue crown lengthening;

¢ Laser root canal disinfection after endodontic treatment;

Er:YAG laser (2940 nm wavelength) in dermatology and other surgical areas:

The LightWalker Er:YAG laser is intended for surgical incision/excision, cutting, ablation, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.

* Dermatology and Plastic Surgery Indications: epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and soft tissue resurfacing;

¢ ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia;

¢ Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectomy;

¢ Uvulopalatoplasty by laser resurfacing;

¢ 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;

¢ Ophthalmology Indications: Soft tissue surrounding the eye;

Intended 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 curettage; Laser removal of porcelain and ceramic crowns and veneers; Flap preparation – incision of soft-tissue to prepare a flap and expose the bone; Cutting bone to prepare a window access to the apex (apices) of the root(s); Root-end preparation for retrofill amalgam or composite; Full thickness flap; Partial thickness flap; Split thickness flap; Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium; Excisional and incisional biopsies; Flap preparation – incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions); Frenectomy and frenotomy; Gingival troughing for crown impressions; Gingivectomy; Gingivoplasty; Implant recovery; Root canal debridement and cleaning; Soft tissue crown lengthening; Laser root canal disinfection after endodontic treatment.

Device Description

The Fotona LightWalker Laser System Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. It combines two flashlamp-pumped laser sources in one housing, with optical cavities containing the Er:YAG and Nd:YAG crystals. A diode aiming beam is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical handpiece (in the case of the Er:YAG laser), or, in the case of the Nd:YAG laser, through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end. The Er:YAG laser is intended to be used for incision/excision, cutting, ablation, vaporization and coagulation of soft and hard tissue in dentistry, dermatology and other surgical areas. The Nd:YAG laser is intended to be used for various intra oral treatments in dentistry, and for various surgical and aesthetic applications in dermatology and other surgical areas.

Summary parsed at:2026-06-01 05:41:56 UTC

Predicate devices

2

K202985 references 2 predicate/reference devices

Cited as predicate

3

3 submissions cite K202985 as a predicate