(205 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, 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:YAG 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, gingivectorny;
- 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 mosaic verrucae, matrixectorny;
- Ophthalmology 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 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
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. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins
Treatment of wrinkles
Treatment of mild to moderate inflammatory acne vulgaris
General surgery indications: surgical incision, excision, 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, excision, and coagulation of soft tissue) including: Matrixectomy
Periungual and subungual warts
Plantar warts
Radical nail excision
Neuromas
The Fotona Light Walker Laser System Family is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).
The Fotona Light Walker Laser System Family is based on Er: YAG (2940 nm) and Nd: YAG (1064 nm) laser technology. The laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The unit 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 nm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical manual or scanner hand piece (in the case of the Er: YAG laser), or through an optical fiber delivery system to an optical manual or scanner hand piece (in the case of the Nd: YAG laser). Optionally, the Nd: YAG therapeutic and aiming laser beams can be guided through a fiber having a connector on the proximal end and a bare fiber on the distal end. Fotona's power supply Variable Square Pulse (VSP) Technology, integrated into the laser system, allows control of the laser pulse duration. The user activates laser emission by means of a footswitch.
This submission is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a performance study against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment for a performance study is not available in this document.
The document states: "The Fotona LightWalker Er:YAG/Nd:YAG Laser System Family is substantially equivalent to Fotona LightWalker Laser System Family (K101817), Fotona Fidelis III Er:YAG/Nd: YAG Laser System Family (K093162), Fotona Dynamis Er:YAG/Nd:YAG Laser System Family (K101306), Fotona XP Nd:YAG Laser System Family (K090126) and (K113702), Cutera GenesisPlus Laser System (K103626) and PinPointe FootLaser (K093547). The Fotona LightWalker Er: YAG/Nd:YAG Laser System Family is substantially equivalent in terms of indications for use and technology based on technical characteristics."
This means the "study" demonstrating the device meets "acceptance criteria" (in the context of a 510(k)) is the comparison of technical specifications and intended uses to already cleared predicate devices. The "acceptance criteria" are effectively the specifications and intended uses of those predicate devices.
Here's the information that can be extracted, with explanations for what is not applicable or not provided:
1. Table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission, the "acceptance criteria" are the technical specifications and intended uses of the predicate devices. The "reported device performance" is the new device's technical specifications.
Table of Comparison for Nd:YAG Laser Wavelength
| Characteristic | Acceptance Criteria (e.g., Predicate Devices) | Reported Device Performance (Fotona LightWalker Family - new submission) |
|---|---|---|
| Wavelength | 1064 nm (across all predicates) | 1064 nm |
| Laser media | Flashlamp pumped solid state rod (across all predicates) | Flashlamp pumped solid state rod |
| Aiming beam | 650 nm (across most predicates) | 650 nm or optionally 635 nm |
| Output mode | Pulsed (across all predicates) | Pulsed |
| Pulse energy | up to 10 J (K093162, K101817), up to 50 J (K101306), up to 20 J (K090126, K113702) | up to 10 J |
| Pulsewidth | 0.1-25 ms (K093162, K101817), 0.1-50 msec (K101306, K090126, K113702) | 0.1-25 ms |
| Repetition rate | up to 100Hz (K093162, K101817, K090126, K113702), up to 50 Hz (K101306) | up to 100Hz |
| Power | up to 15 W (K093162, K101817), up to 80 W (K101306), up to 30 W (K090126, K113702) | up to 15 W |
| Beam delivery | Fiber (across all predicates) | Fiber |
| User interface | Push button control (K093162, K101306, K090126, K113702), Touch screen control (K101817) | Touch screen control |
Table of Comparison for Er:YAG Laser Wavelength
| Characteristic | Acceptance Criteria (e.g., Predicate Devices) | Reported Device Performance (Fotona LightWalker Family - new submission) |
|---|---|---|
| Wavelength | 2940 nm (across all predicates) | 2940 nm |
| Laser media | Flashlamp pumped solid state rod (across all predicates) | Flashlamp pumped solid state rod |
| Aiming beam | 650 nm (across all predicates) | 650 nm or optionally 635 nm |
| Output mode | Pulsed (across all predicates) | Pulsed |
| Pulse energy | 25-1500 mJ (K093162), 20-1500 mJ (K101817), 30-1500 mJ (K101306) | 5-1500 mJ |
| Pulsewidth | 50-1000 µs (K093162, K101817), 100-1500 µs (K101306) | 50-1000 µs |
| Repetition rate | up to 50 Hz (across all predicates) | up to 50 Hz |
| Power | up to 20 W (across all predicates) | up to 20 W |
| Beam Delivery | Articulated arm (across all predicates) | Articulated arm |
| User interface | Push button control (K093162, K101306), Touch screen control (K101817) | Touch screen control |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. This is a 510(k) submission based on substantial equivalence, not a clinical trial with a "test set" in the traditional sense for evaluating diagnostic performance or clinical outcomes. The "test" is the comparison of technical specifications and intended uses.
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. No "ground truth" for a performance study was established as part of this submission. The "ground truth" for substantial equivalence is the FDA's prior clearance of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. There was no "test set" requiring adjudication.
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 surgical laser, not an AI-based diagnostic tool. No MRMC studies were conducted or are relevant to this type of device and submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This is not an algorithm-only device. It is a physical laser system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this 510(k) submission is the FDA's prior clearance of the predicate devices, meaning their safety and effectiveness for their stated indications have already been accepted by the regulatory body.
8. The sample size for the training set
- Not Applicable / Not Provided. There is no "training set" as this is not an AI/machine learning device. The "training" in a broad sense involved the design and testing of the laser system to ensure it met its own engineering specifications, but this is not reported in terms of a "training set."
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. As there is no training set mentioned, no ground truth for it was established.
§ 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.