(170 days)
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 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, 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:
The LightWalker Er: YAG laser is intended for surgical incision/excision, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.
· Dermatology and Plastic Surgery Indications: epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and soft tissue resurfacing:
· ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia;
- · Oral/Maxillofacial Indications: Oral and glossal lesions, gingivectomy;
· Uvulopalatoplasty by laser resurfacing
· 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, valvar lesions, polyps and familial polyps of the colon;
· Dermatological procedures requiring resurfacing of soft tissue with Fotona FS-01 fractionated handpiece.
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 toothmobility): - · 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, 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.);
· Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicosities.
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 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 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 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 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 describes a 510(k) premarket notification for the Fotona LightWalker Laser System Family, which is a medical laser system. The document focuses on establishing substantial equivalence to predicate devices and does not detail specific acceptance criteria or a study that evaluates the device's performance against such criteria in the context of clinical outcomes or diagnostic accuracy. Instead, the "acceptance criteria" discussed are related to regulatory compliance and safety standards, and the "study" is a non-clinical summary of verification and validation tests.
Therefore, the requested information elements related to device performance (e.g., accuracy, sensitivity, specificity), ground truth, sample sizes for test and training sets, expert qualifications, adjudication methods, and MRMC studies are not applicable to this document as it does not present a clinical performance study of this nature.
Here's the information that can be extracted based on the provided text, primarily focusing on the regulatory and technical aspects:
1. Table of Acceptance Criteria and Reported Device Performance
As this document does not present a clinical performance study with acceptance criteria for metric-based performance (e.g., sensitivity, specificity, accuracy), the "acceptance criteria" here refer to compliance with safety and performance standards. The "reported device performance" refers to the device meeting these standards.
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance (Compliance Statement) |
|---|---|
| EN 60601-1:2006 + A1:2013 (Medical Electrical Equipment - General requirements for basic safety and essential performance) | Device designed, tested, and will be manufactured in accordance with this standard. |
| EN 60601-1-2:2015 (Medical Electrical Equipment - Electromagnetic disturbances) | Device designed, tested, and will be manufactured in accordance with this standard. |
| EN 60601-2-22:2013 (Medical Electrical Equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic and diagnostic laser equipment) | Device designed, tested, and will be manufactured in accordance with this standard (company followed current state of the art assuming newer standards assure a higher level of safety). |
| EN 60601-1-6:2010 + A1:2015 (Medical Electrical Equipment - Usability) | Device designed, tested, and will be manufactured in accordance with this standard. |
| EN 62366:2008 + A1:2015 (Medical devices - Application of usability engineering) | Device designed, tested, and will be manufactured in accordance with this standard. |
| EN 60825-1:2014 (Safety of laser products - Equipment classification and requirements) | Device designed, tested, and will be manufactured in accordance with this standard. |
| EN ISO 14971:2012 (Medical devices - Application of risk management) | Device designed, tested, and will be manufactured in accordance with this standard. |
| EN 62304:2006 + A1:2015 (Medical device software - Software life-cycle processes) | Device designed, tested, and will be manufactured in accordance with this standard. |
| EN ISO 17664:2017 (Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices) | Device designed, tested, and will be manufactured in accordance with this standard. |
| EN ISO 10993-1:2009 (Biological evaluation of medical devices - Evaluation and testing within a risk management process) | Device designed, tested, and will be manufactured in accordance with this standard. |
| Other international/CB Scheme/ISO standards (IEC 60601 series, IEC 60825-1, IEC 62366, IEC 62304, ISO 14971, ISO 17664, ISO 10993-1) | Device designed, tested, and will be manufactured in accordance with these standards. |
| Substantial Equivalence to Predicate Devices | The device's indications for use and technological characteristics do not raise new types of questions regarding safety and efficacy when compared to the predicates. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The document describes a substantial equivalence submission based on non-clinical testing and comparison to predicate devices, not a clinical study with a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No experts were used to establish ground truth for a clinical test set as no such study is described.
4. Adjudication method for the test set:
- Not Applicable. No test set or related adjudication process is described.
5. 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. No MRMC study or AI component is mentioned. This is a laser device cleared for surgical procedures.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a laser system, not an algorithm. Its operation inherently involves a human operator and it does not have "standalone" performance in the context of an algorithm.
7. The type of ground truth used:
- Not Applicable. The "ground truth" for this regulatory submission is compliance with established safety and performance standards for medical devices and establishing substantial equivalence based on technical characteristics and intended use. No clinical ground truth (e.g., pathology, outcomes data) is presented in this document.
8. The sample size for the training set:
- Not Applicable. This document does not describe a machine learning algorithm or a training set.
9. How the ground truth for the training set was established:
- Not Applicable. This document does not describe a machine learning algorithm or a training set.
§ 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.