(74 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
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 imflamed 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
- Vestibuloplastv
- Laser assisted new attachment procedure (cementum-mediated periodontal ligament now-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 reatment 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, hemaongiomae, 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, menibrane, 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
The Fotona LightWalker Laser System Family is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).
The device is Fotona LightWalker laser system family (same as K121508). 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 hand piece (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 hand piece 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 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 document is a 510(k) premarket notification for the Fotona LightWalker Laser System Family. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing extensive clinical trials with specific acceptance criteria as you might see for a novel, high-risk device or a new indication that significantly changes the device's fundamental technology or safety profile.
Based on the document, here's an analysis addressing your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" in the typical sense (e.g., a specific sensitivity or specificity threshold for a diagnostic AI, or a success rate for a therapeutic device in a clinical trial). Instead, the acceptance criteria for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to existing predicate devices.
The "performance" is demonstrated through:
- Comparison of Technological Characteristics: Showing that the LightWalker Laser System Family has the same fundamental design, energy sources, wavelengths, power output, pulse characteristics, and beam delivery systems as the predicate devices.
- Comparison of Intended Use/Indications for Use: Demonstrating that the new indications for use (Laser Assisted New Attachment Procedure and Periodontal Regeneration) fall within the scope of what the predicate devices can achieve with similar parameters.
Here's how the document frames the comparison, which serves as the "reported device performance" against the implicit "acceptance criteria" of being substantially equivalent to the predicates:
| Feature/Indication | Acceptance Criteria (Implicit - based on Predicate) | Reported Device Performance (Fotona LightWalker K172819) |
|---|---|---|
| General Technological Characteristics (LightWalker vs. Predicates K070355 & K151763) | Same design, chemical composition, energy source, wavelength, active medium, cooling system, power supply, beam delivery, controls, housing. Output characteristics for intended use are the same. | "The Fotona LightWalker Laser System Family has the same technological and design characteristics... as the previously cleared Fotona's LightWalker Laser System family Device (K121508) and the predicate devices Fotona Fidelis III Er:YAG/Nd: YAG Laser System (K070355) and PerioLase Nd: YAG Pulsed Dental Laser System (K151763). The output characteristics are for the intended use the same as those of the predicate devices." (Page 8) |
| New Indication: Laser assisted new attachment procedure (Nd:YAG in dentistry) vs. Fotona Fidelis III (K070355) | Wavelength: 1064nm, Contact part: Bare fiber, Power: 2-4W, Pulsewidth Mode: SP/LP, Frequency: 10-20Hz, Fiber diameter: 300 µm | All parameters match the predicate (Wavelength: 1064nm, Contact part: Bare fiber, Power: 2-4W, Pulsewidth Mode: SP/LP*, Frequency: 10-20Hz, Fiber diameter: 300 µm). (*SP and LP LightWalker's modes denote pulse durations 150 µs and 650 µs, respectively.) (Table 1, Page 9) |
| New Indication: Periodontal regeneration (Nd:YAG in dentistry) vs. Periolase Nd: YAG (K151763) | Wavelength: 1064nm, Contact part: Bare fiber, Power: 3-4W, Pulsewidth: 150 µs and 650 µs, Frequency: 20Hz, Fiber diameter: 360-400 µm | All parameters match the predicate (Wavelength: 1064nm, Contact part: Bare fiber, Power: 3-4W, Pulsewidth: 150 µs and 650 µs, Frequency: 20Hz, Fiber diameter: 360 µm - 400 µm). (Table 2, Page 9) |
| Compliance with Standards | Compliance with relevant IEC/EN standards for medical electrical equipment, laser safety, usability, risk management, and software lifecycle processes. | The device "is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards" listed in detail on page 10. (e.g., EN 60601-1, EN 60825-1, EN ISO 14971, EN 62304). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical testing was needed." (Page 10).
This means there was no "test set" in the sense of a patient cohort or retrospective dataset for performance evaluation the device's clinical efficacy or safety, beyond its substantial equivalence to the predicate devices. The data provenance is implied to be through the design specifications and laboratory testing against standards, not from clinical patient data.
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, as no clinical testing was performed and no ground truth was established from patient data. The "ground truth" for this 510(k) submission is the established performance and safety of the predicate devices and the technical specifications of the new device demonstrating equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical testing or human review of clinical data was performed.
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. This is a laser surgical instrument, not a diagnostic AI device requiring MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (laser system), not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) is the established safety and efficacy profiles of the predicate devices. The manufacturer's argument for substantial equivalence relies on the new device having the same fundamental technology and operating parameters for the new indications as devices already cleared by the FDA. Laboratory testing confirmed the device's technical specifications met relevant standards.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device that requires a training set. The "training" for this device's design and manufacturing is based on established engineering principles and compliance with recognized standards.
9. How the ground truth for the training set was established
Not applicable.
§ 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.