LogoFDA 510(k) Search
K Number
K242202
Device Name
LightWalker Laser System Family
Manufacturer
Fotona d.o.o.
Date Cleared
2024-08-23

(28 days)

Product Code
GEX
Regulation Number
878.4810
Type
Special
Panel
SU
Reference & Predicate Devices
K202985
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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 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 Iming 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, cutting, ablation, 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, vulvar 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 no 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, excision, 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.

Device Description

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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for the Fotona LightWalker Laser System Family. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies is not explicitly available in this type of regulatory submission.

Here's why and what information is provided:

1. A table of acceptance criteria and the reported device performance:

  • Not provided. The document does not specify quantitative acceptance criteria or detailed device performance metrics in a table. It primarily states that "performance testing was conducted on the subject device, and it was established that the newly introduced features do not raise different questions of safety or effectiveness."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

  • Not provided. The document states "Clinical testing was not considered to be needed for this pre-market notification." Therefore, there is no information on sample sizes or data provenance for a clinical test set. The submission relies on non-clinical performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

  • Not applicable/Not provided. Since no clinical testing was deemed necessary, there was no test set requiring expert-established ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

  • Not applicable/Not provided. As no clinical test set was used, no adjudication method is mentioned.

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/Not provided. This device is a laser system, not an AI-powered diagnostic tool, so MRMC studies comparing human reader performance with and without AI assistance are not relevant to this submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

  • Not applicable/Not provided. This is a physical laser device, not a standalone algorithm. Performance testing was likely focused on the physical characteristics of the laser system (e.g., wavelength, power, pulse energy, safety standards adherence).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

  • Not applicable/Not provided. For the non-clinical performance testing the device underwent, the "ground truth" would be established by engineering specifications and standard test methods (e.g., measurement of laser output parameters) rather than clinical ground truth methods like pathology or expert consensus.

8. The sample size for the training set:

  • Not applicable/Not provided. Since "Clinical testing was not considered to be needed" and the device is not an AI/machine learning product requiring a training set, this information is not relevant or available.

9. How the ground truth for the training set was established:

  • Not applicable/Not provided. As there is no training set for this type of device, ground truth establishment for a training set is not applicable.

Summary of what is provided regarding testing and equivalence:

The submission focuses on demonstrating substantial equivalence to a predicate device (K202985 LightWalker Laser System Family) based on:

  • Non-clinical Performance Testing: The device underwent performance testing to ensure that its newly introduced features (primarily a change in operating system from Windows to Linux and a larger user interface screen) do not raise new questions of safety or effectiveness.
  • Adherence to Standards: The device successfully completed tests based on various IEC and ISO standards related to medical electrical equipment, laser safety, usability, risk management, and software lifecycle processes.
    • Performance Standards Listed:
      • IEC 60601-1:2005 + A1:2012 + A2:2020 (General requirements for basic safety and essential performance)
      • IEC 60601-1-2:2014 + A1:2020 (Electromagnetic disturbances)
      • IEC TR 60601-4-2:2016 (Electromagnetic immunity)
      • IEC 60601-2-22:2019 (Particular requirements for surgical, cosmetic, therapeutic and diagnostic laser equipment)
      • IEC 60601-1-6:2010 + A1:2013 + A2:2020 (Usability)
      • IEC 60601-1-9:2007 + A1:2013 (Environmentally conscious design)
      • IEC 60825-1:2014 (Safety of laser products)
      • IEC 62366:2007 + A1:2014 / IEC 62366-1:2015 (Usability engineering)
      • IEC 62304:2006 + A1:2015 (Medical device software life-cycle processes)
      • ISO 14971:2019 (Risk management)
      • ISO 17664-1:2021 & ISO 17664-2:2021 (Processing of health care products)
      • ISO 10993-1:2018 (Biological evaluation of medical devices)
    • Guidance Documents Applied:
      • FDA Guidance (2023), "Content of Premarket Submissions for Device Software Functions" (Software Verification and Validation Testing)
      • FDA Guidance (2023), "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" (Cybersecurity testing)
  • Technological Characteristics Comparison: The document provides a table comparing the technological characteristics of the subject device (K242202) and the predicate device (K202985), showing identical laser output parameters (wavelength, laser media, output mode, pulse energy, pulsewidth, repetition rate, power, beam delivery). The only differences noted are the Operating System (Linux vs. Windows) and the User Interface Screen Size (10.1" vs. 8.4").

The core of this submission is that performance testing against these engineering standards, combined with the identical intended use and very similar technological characteristics relative to the predicate, establishes that the device is substantially equivalent and thus does not require clinical studies.

§ 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.