(199 days)
The Fotona Fidelis Plus Nd:YAG Laser System and Accessories is intended for incision, excision and coagulation of intraoral soft tissue, including the marginal and interdental gingiva. This includes incising, excising and coagulating the epithelium lining, the free or marginal gingiva, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).
- Excisional and incisional biopsies
- Excision and vaporization of herpex 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)
- Leukoplakia
- 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 bleeding index, probe depth, attachment loss, and tooth mobility)
- Tissue retraction for impression
- Treatment of apthous ulcers
- Vestibuloplasty
The Fotona Fidelis Plus Nd:YAG system is a microprocessor controlled device which generates laser light with a wavelength of 1064 nm when used in conjunction with a host Fidelis Er: YAG system. When combined, the Nd: YAG (1064 nm) accessory and the host Er: Y AG system constitute the Fidelis Plus laser system.
The Fotona Fidelis Plus Nd:YAG system is designed as an accessory for use with the Fotona Fidelis Er:YAG laser system. The Nd:YAG (1064 nm) sub-system is functionally integrated to the host laser system. When integrated, the host laser system recognizes the presence of the accessory and permits activation of the 1064 nm pulsed light via the same touchscreen as the host Er: Y AG.
The Fidelis Plus Nd:YAG laser system consists of 3 major sub-systems:
a) An optical delivery system, interfacing the energy from the laser to the patient via an optical fiber and a handpiece.
b) An electronic power supply and interface circuitry.
c) An optical chamber containing laser rod and laser cavity optics.
The provided text is a 510(k) premarket notification for a medical device (Fotona Fidelis Plus Nd:YAG Laser System and Accessories). It does not contain information about acceptance criteria, device performance from a study, or details related to clinical trials with human subjects, AI assistance, or ground truth establishment.
The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, the Sunlase 800P Nd:YAG laser system, based on technological characteristics and intended use.
Therefore, I cannot provide the requested information for acceptance criteria, device performance, sample size for test/training sets, expert qualifications, or adjudication methods because this type of data is not present in the provided text.
The document highlights:
- Intended Use: Incision, excision, and coagulation of intraoral soft tissue, including marginal and interdental gingiva, along with specific procedures like gingivectomy, frenectomy, and sulcular debridement.
- Technological Equivalence: Both the Fotona device and the predicate device use a flashlamp-pumped Nd:YAG laser rod generating 1064 nm light, delivered via an optical fiber system.
- Risk and Benefit Comparability: Fotona asserts that the risks and benefits are comparable to predicate devices for similar clinical applications.
§ 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.