(88 days)
2940 nm Er:YAG Laser 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 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
-Full thickness flap
-Partial thickness flap
-Split thickness flap
-Laser removal of diseased, infected, 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
-Gingivoplasty
-Implant recovery
-Root canal debridement and cleaning
-Soft tissue crown lengthening
-Laser root canal disinfection after endodontic treatment
2940 nm Er:YAG Laser in dermatology and other surgical areas:
-Dermatology and Plastic Surgery Indications: Skin resurfacing, epidermal nevi, verrucae, skin tags, keratoses, treatment of wrinkles
-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 mosaic verrucae
-Ophthalmology Indications: Soft tissue surrounding the eye
-Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma
-Genitourinary Indications: Lesions of the external genis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon
1064 nm Diode Laser in dentistry:
-Excisional and incisional biopsies
-Excision and vaporization of herpes simplex I and II
-Frenectomy and frenotomy
-Gingivectomy
-Gingivoplasty
-Gingival incision and excision
-Hemostasis
-Implant recovery
-Operculectomy
-Pulpotomy and pulpotomy as an adjunct to root canal therapy
-Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy
-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)
-Treatment of aphthous ulcers and herpetic lesions
1064 nm Diode Laser in dermatology and other surgical areas:
-General surgery indications: surgical incision, vaporization and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cattillage, 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.)
1064 nm Diode Laser in 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.
670 nm Diode Laser in low level laser therapy:
-Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.
808 nm Diode Laser in dentistry:
Incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following:
-Gingival troughing for crown impression
-Gingivectomy
-Gingivoplasty
-Gingival incision and excision
-Hemostasis and coagulation
-Excisional and incisional biopsies
-Fibroma removal
-Frenectomy and frenotomy
-Oral papillectomies
-Soft tissue crown lengthening
-Treatment of aphthous ulcers
-Treatment of herpetic lesions
Periodontology:
-Laser soft tissue curettage,
-Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
Cosmetic Dentistry:
-Laser-assisted bleaching/whitening of the teeth,
-Light activation for bleaching materials for teeth whitening
Implant recovery
808 nm Diode Laser in therapy:
-Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
980 nm Diode Laser in dentistry:
-Gingival troughing
-Crown lengthening
-Gingivoplasty
-Coagulation
-Hemostasis of donor site
-Implant recovery
-Implant uncovery
-Soft tissue curettage
-Sulcular debridement
-Biopsy
-Frenectomy
-Operculectomy
-Exposure of unerupted teeth
-Pulpotomy
-Treatment of aphthous ulcers
-Excision of lesions
-Light activation of bleaching materials for teeth whitening
1470 nm Diode Laser:
-Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue
-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux
1940 nm Diode Laser:
-Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue
The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attachable laser modules. The Fotona SkyPulse Laser Platform is a multi-application, multi-technology platform that supports the following modules: i) Flash-lamp pumped solid state laser modules and ii) Diode laser modules. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system microcontroller through an LCD touch-screen. The console allows simultenous attachment of a solid state laser module and a diode module with up to three selectable diode laser wavelengths.
The following therapeutic laser modules are currently available with the SkyPulse platform: 2940 nm Er:YAG Laser Module, 1064 nm Diode Laser Module, 808 nm Diode Laser Module, 670 nm Diode Laser Module, 980 nm Diode Laser Module, 1470 nm Diode Laser Module and 1940 nm Diode Laser Module. A diode aiming beam is combined with all therapeutic laser beams. The combined therapeutic and aiming beams are guided either through an articulated arm to an optical handpiece (in the case of the Er: YAG laser), or through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end.
This FDA 510(k) summary describes a multi-wavelength laser platform (Fotona SkyPulse Laser Platform) and its substantial equivalence to previously cleared medical laser systems. The document states that no clinical testing was needed for this device. Therefore, the questions related to clinical study design, sample size, ground truth establishment, expert adjudication, and MRMC studies are not applicable.
The acceptance criteria for this device are based on demonstrating that it meets various mandatory and voluntary standards for medical electrical equipment, particularly for laser surgical equipment. The "study" proving the device meets these criteria is laboratory testing to ensure it adheres to these standards and that its design specifications align with those of predicate devices.
Here's the breakdown of the requested information, adapted to reflect that no clinical study was performed:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a laser device and no clinical data is presented, the "acceptance criteria" are embodied in the compliance with recognized standards, and the "reported device performance" refers to the device meeting the technical specifications and safety requirements outlined in those standards. The document provides tables comparing the technical specifications of the Fotona SkyPulse Laser Platform with several predicate devices, serving as evidence of similar performance and characteristics.
| Acceptance Criterion (Standard Compliance) | Reported Device Performance (as demonstrated by comparison and lab testing) |
|---|---|
| EN 60601-1:2006 + A1:2013 | Meets general requirements for basic safety and essential performance. |
| EN 60601-1-2:2015 | Meets electromagnetic compatibility requirements. |
| EN 60601-2-22:2013 | Meets particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment. |
| EN 60601-1-6:2010 + A1:2015 | Meets general requirements for basic safety and essential performance - Collateral standard: Usability. |
| EN 62366:2008 + A1:2015 | Meets requirements for the application of usability engineering to medical devices. |
| EN 60825-1:2014 | Meets requirements for safety of laser products and equipment classification. |
| EN ISO 14971:2012 | Application of risk management to medical devices demonstrated. |
| EN 62304:2006 + A1:2015 | Meets medical device software life-cycle processes. |
| EN ISO 17664:2004 | Meets sterilization requirements (information for processing resterilizable medical devices). (Transition to newer version underway) |
| EN ISO 10993-1:2009 | Meets biological evaluation of medical devices (evaluation and testing within a risk management process). (Transition to newer version underway) |
| Technical Specifications (Tables 1-7) | Device's energy source, wavelength, aiming beam, power, energy per pulse, pulse width, repetition rate, delivery system, and user interface are comparable to predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: This is not applicable as no clinical test set was used for this 510(k) submission. The evaluation was based on demonstrating compliance with recognized standards and comparison to predicate devices, supported by laboratory testing.
- Data Provenance: Not applicable for a clinical test set. The technical specifications and performance data are derived from the device's design, manufacturing, and laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as no clinical test set or human-interpreted ground truth was used. The ground truth for device safety and performance is established by adherence to engineering specifications and international/national standards, verified through laboratory testing.
4. Adjudication method for the test set
- Not applicable as no clinical test set requiring human adjudication was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, a multi-reader multi-case comparative effectiveness study was not done. The device is a laser system, not an AI-assisted diagnostic tool that would typically undergo such a study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a laser surgical instrument, and the concept of "standalone performance" in the context of an algorithm or AI without human-in-the-loop performance is not relevant. Its performance is assessed through its technical specifications and safety features.
7. The type of ground truth used
- The "ground truth" for this submission is adherence to technical specifications, engineering design, and compliance with recognized national and international electrical, medical device, and laser safety standards, as demonstrated through laboratory testing.
8. The sample size for the training set
- Not applicable as this is not a machine learning device and therefore does not have a training set.
9. How the ground truth for the training set was established
- Not applicable as this is not a machine learning device and therefore does not have a training set.
In summary, the Fotona SkyPulse Laser Platform's acceptance was based on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and compliance with a comprehensive list of medical device and laser safety standards, verified by laboratory testing, rather than through clinical studies or AI model evaluations.
§ 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.