(145 days)
The LightWalker Er:YAG laser, and its accessories, are intended for use in dentistry, dermatology and other surgical areas in the following procedures:
In dentistry, for:
- Intra-oral soft tissue surgery (incision, excision, ablation, coagulation)
- Leukoplakia
- Pulpotomy as adjunct to root canal retreatment
- Pulp extirpation
- Removal of fibromae
- Removal 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
In dermatology and other surgical areas, for:
- Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, skin tags, keratoses, verrucae, 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 mosiac verrucae, matrixectomy
The LightWalker Nd:YAG laser, and its accessories, are intended for use in dentistry, dermatology and other surgical areas in the following procedures:
In dentistry, for:
- 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 imflamed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss, and tooth mobility)
- Tissue retraction for impression
- Treatment of aphtous ulcers
- Vestibuloplasty
In dermatology and other surgical areas, for:
- 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 lessons, such as, but not limited to, port wine stains, hemaongiomae, warts, telengiectasiae, venus lake, leg veins and spider veins
- Treatment of wrinkles
- Treatment of mild to moderate inflammatory acne vulgaris
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 red diode aiming beam (650 mm) 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 through an optical fiber delivery system to an optical hand piece (in the case of the Nd: YAG laser).
The Er:YAG laser is capable of delivering up to 1.5 J of laser energy in pulses with durations of up to 1000 us and frequencies (repetition rates) of up to 50 Hz. The maximum average output power is 20 W.
For aesthetic indications, the Nd:YAG laser is capable of delivering laser fluences up to 300 J/cm² in pulses with durations of up to 25 ms. For dental indications, it is capable of delivering laser pulses with durations of up to 320 us, frequencies (repetition rates) up to 100 Hz and a maximum output power of 15 W.
Fotona's power supply Variable Square Pulse (VSP) Technology, integrated into the laser system, allows ultimate control of the laser energy and the laser pulse duration. This ensures treatment precision, patient comfort, safety and ease-of-use in all treatments.
The provided text is a 510(k) summary for the Fotona LightWalker Laser System Family. This document focuses on establishing substantial equivalence to a predicate device and outlines the intended uses and technical specifications of the laser system. It does not contain information about acceptance criteria, detailed study designs, sample sizes, ground truth establishment, or multi-reader multi-case (MRMC) studies typically associated with validating algorithms or AI-powered devices.
Therefore, I cannot provide the requested information in the format of a table or answer many of the specific questions because the document does not contain this type of data.
Here's what can be inferred or explicitly stated based on the provided text, along with what cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a study. The primary "acceptance" criteria for a 510(k) submission are based on demonstrating substantial equivalence to a predicate device, meaning it has similar indications for use, design, and functional features, and does not raise new questions of safety or effectiveness.
- Reported Device Performance: The document describes the technical specifications (e.g., laser wavelengths, energy, pulse durations, repetition rates, maximum average output power, fluence) but does not present performance metrics (e.g., accuracy, sensitivity, specificity) against specific clinical outcomes or ground truth for the stated indications.
2. Sample size used for the test set and data provenance:
- Not applicable as no performance study data against a test set is provided. The submission is a comparison to a predicate device, not a de novo clearance requiring clinical validation of performance.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable as no performance study data against a test set is provided.
4. Adjudication method for the test set:
- Not applicable as no performance study data against a test set is provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- No. This document does not mention an MRMC study or any AI component. The device described is a laser system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, as the device is a laser system, not an algorithm.
7. The type of ground truth used:
- Not applicable as no performance study data against a test set is provided. The "ground truth" for a 510(k) for a non-AI device like this is the established safety and effectiveness of the predicate device and relevant scientific literature for the stated indications.
8. The sample size for the training set:
- Not applicable as no AI or algorithm training is mentioned.
9. How the ground truth for the training set was established:
- Not applicable as no AI or algorithm training is mentioned.
Summary of the K101817 Submission Content:
The Fotona LightWalker Laser System Family (K101817) is an Er:YAG/Nd:YAG laser system. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device: Fotona Fidelis III Er:YAG/Nd:YAG Laser System Family (K093162).
The document lists extensive intended uses and indications for both the Er:YAG and Nd:YAG lasers in dentistry, dermatology, ENT surgery, oral/maxillofacial surgery, general surgery, and podiatry. These indications range from soft tissue surgery, caries removal, skin resurfacing, hair reduction, and treatment of vascular lesions.
The justification for substantial equivalence is based on the same indications for use, similar design, and functional features compared to the predicate device. This is a common pathway for device clearance and usually does not involve new clinical studies to prove efficacy against specific acceptance criteria for a novel algorithm or diagnostic tool. Instead, it relies on the known performance and safety profile of similar, legally marketed devices.
§ 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.