(86 days)
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 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, 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: 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
- · 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 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 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, 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 stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle.
*Note: Permanent hair reduction is defined as the long-term, stable redction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
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 flashlamppumped 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, 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 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 intra oral treatments in dentistry, and for various surgical and aesthetic applications in dermatology and other surgical areas.
The provided text is a 510(k) Summary for the Fotona LightWalker Laser System Family. This document is related to a medical device (a laser system), not an AI/ML-based device, and therefore the acceptance criteria and study details that would typically apply to an AI/ML device (such as those involving performance metrics like sensitivity, specificity, AUC, and the rigorous ground truth establishment, reader studies, etc., that are characteristic of AI/ML device submissions) are not present in this document.
The document primarily focuses on demonstrating substantial equivalence to predicate devices by comparing technical specifications and showing compliance with relevant safety and performance standards for laser systems.
Here's why the document does not contain the information requested and what information it does provide:
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A table of acceptance criteria and the reported device performance: This sort of table, specifically with quantitative performance metrics (e.g., sensitivity, specificity, accuracy) against pre-defined acceptance thresholds, is characteristic of AI/ML device submissions. For this laser device, the "acceptance criteria" are compliance with established medical device standards (e.g., IEC 60601 series, ISO 14971) and demonstration of equivalent technical specifications to predicate devices. The "reported device performance" is essentially that it meets these standards and functions as intended, and its technical specifications are comparable to cleared devices.
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Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the sense of a dataset for evaluating an AI model. The testing refers to engineering and compliance testing (e.g., electrical safety, EMC, laser safety standards), not performance evaluation on a patient dataset. The document explicitly states: "Clinical testing: No clinical testing was needed."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in the context of AI/ML refers to validated labels for a dataset, typically established by expert readers or pathology. For a laser device, there's no such "ground truth" to establish for a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there is no test set or human interpretation involved in the performance evaluation described.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a study design specific to evaluating the clinical impact of AI assistance on human readers. The device is a laser system, not an AI software.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm to evaluate in a standalone manner.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as explained above.
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The sample size for the training set: Not applicable. There is no AI model that requires a training set.
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How the ground truth for the training set was established: Not applicable.
What the document does provide regarding "acceptance criteria" and "study":
Acceptance Criteria (Implicit through comparison and standards compliance):
- Identical or similar technological and design characteristics to legally marketed predicate devices (Fotona LightWalker Laser System Family (K191554), Biolase WaterLase Laser System Family (K190319), Fotona Dynamis Pro Laser System Family (K182088)).
- Similar output characteristics to predicate devices for the proposed intended use.
- Compliance with applicable mandatory and voluntary standards, including:
- EN 60601-1 (Medical electrical equipment – General requirements for basic safety and essential performance)
- EN 60601-1-2 (Electromagnetic compatibility)
- EN 60601-2-22 (Particular requirements for surgical, cosmetic, therapeutic and diagnostic laser equipment)
- EN 60601-1-6 (Usability)
- EN 62366 (Usability engineering)
- EN 60825-1 (Safety of laser products)
- EN ISO 14971 (Risk management)
- EN 62304 (Medical device software)
- EN ISO 17664 (Sterilization information)
- EN ISO 10993-1 (Biological evaluation)
- Corresponding IEC standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, IEC 62304, IEC 62366).
Device Performance (as reported within the context of the 510(k) submission):
The device performance is demonstrated by its technical specifications being comparable to predicate devices and by its compliance with relevant safety and performance standards.
Table: Comparison of Technical Specifications (from the document)
| Characteristic | LightWalker Laser System Family (K191554) | WaterLase Laser System Family (K190319) | Dynamis Pro Laser System Family (K182088) | LightWalker Laser System Family (this submission) |
|---|---|---|---|---|
| Energy source | Solid state Er:YAG | Solid state Er,Cr:YSGG | Solid state Er:YAG | Solid state Er:YAG |
| Wavelength | 2940 nm | 2780 nm | 2940 nm | 2940 nm |
| Aiming beam | Laser diode 635nm/650nm (red) or 520-532nm (green); |
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.