Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
2940 nm Er:YAG Laser 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 2940 nm Er:YAG Laser 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 – Ophthalmology Indications: Soft tissue surrounding the eye – Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condyloma – Genitourinary Indications: Lesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon 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 freno
2940 nm Er:YAG Laser 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 – 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 2940 nm Er:YAG Laser 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
The device is Fotona LightWalker laser system family (same as K191554). It 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 capable of delivering up to 1.5 J of laser energy in pulses with durations of 50 - 1000 μs and frequencies (repetition rates) of up to 50 Hz. The maximum average output power is 20 W. The 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 capable of delivering up to 10 J of energy with pulse durations from 0.1-25 ms, and frequencies of up to 100 Hz. For dental indications it is capable of delivering laser pulses with durations of up to 650 μs, frequencies (repetition rates) of up to 100 Hz and a maximum output power of 15 W. The 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 05:47:34 UTC
LightWalker Laser System Family
1 submission cite K193661 as a predicate
