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Er: Y A G 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 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: Y AG 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, 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
• · Ophtalmology Indications: Soft tissue surrounding the eye
  · Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma

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 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
  · 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

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-VI, including tanned skin*

• · Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemangiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins
• Treatment of wrinkles
• · Treatment of mild to moderate inflammatory acne vulgaris
  · General surgery indications: surgical incision, vaporization and coagulation of soft tissue. All soft 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, and coagulation of soft tissue) including: Matrixectomy, Periungual and subungual warts, Plantar warts, Radical nail excision, Neuromas.
  · Temporary increase of clear nail in patients with onychomycosis (e.g. dermatophytes Trichophyton rubrum and T mentagrophytes and/or yeasts Candida albicans, etc.)

Nd:YAG laser (1064 nm wavelength) therapy:
· Temporary relief of muscle and joint pain and stiffhess, arthritis pain or muscle spassn. temporary increase in local blood circulation and/or promoting relaxation of muscle.

The device is Fotona LightWalker laser system family (same as K172819). 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 us 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 0.5 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 us, 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 intraoral treatments in dentistry, for various surgical and aesthetic applications in dermatology and other surgical areas, and for pain reduction indication stated below.

The provided text is a 510(k) Summary for the Fotona LightWalker Laser System Family. This document is a premarket notification to the FDA, demonstrating substantial equivalence to previously cleared devices. It does not contain information about clinical studies, acceptance criteria for an AI/CADe device, or performance data of such a device.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for the test set.
5. Results of a multi-reader, multi-case (MRMC) comparative effectiveness study.
6. Standalone performance of an algorithm.
7. Type of ground truth used.
8. Sample size for the training set.
9. Method for establishing ground truth for the training set.

The document discusses the technical specifications and intended uses of a laser system, comparing them to predicate laser systems to assert substantial equivalence for regulatory clearance. It focuses on the device's physical properties (wavelengths, power, pulse characteristics) and its approved applications (e.g., dentistry, dermatology, general surgery, pain relief), rather than the performance of an AI or CADe algorithm.

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