LightWalker Laser System Family

The Fotona LightWalker Laser System Family and its accessories will be marketed for the following indications added in this submission:

Nd:YAG laser (1064 nm wavelength) in dentistry:
– 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.

Fotona LightWalker Laser System Family and its accessories will also be marketed for the following indications for use, already previously cleared under K121508:

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

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;
– Ophthalmology Indications: Soft tissue surrounding the eye;
– Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condyloma;

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 frenotomy
– Gingival troughing for crown impressions
– Gingivectomy
– Gingivoplasty
– Gingival incision and excision
– Hemostasis
– Implant recovery
– Incision and drainage of abscess
– Laser assisted uvulopalatoplasty (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 a

The Fotona LightWalker Laser System Family and its accessories will be marketed for the following indications added in this submission: Nd:YAG laser (1064 nm wavelength) in dentistry: – 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. b) Fotona LightWalker Laser System Family and its accessories will also be marketed for the following indications for use, already previously cleared under K121508: 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.

The device is Fotona LightWalker laser system family (same as K121508). 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 hand piece (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 hand piece 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.