(121 days)
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 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, cartillage, menibrane, 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.)
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.
810 nm Diode Laser in dentistry:
· Surgical applications requiring the ablation, vaporization, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology
- · Oral/Maxillofacial Indications: Incision, excision, vaporization, ablation and/or coagulation of soft tissue
- · 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
810 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:
· Surgical applications requiring the ablation, vaporization, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology and thoracic surgery
- Gingival troughing
- Crown lengthening
- Gingivoplasty •
- · Coagulation
- Implant uncovery
- Implant recovery
- Soft tissue curettage
- Sulcular debridement
- · Biopsy
- · Frenectomy
- Hemostasis of donor site
- Operculectomy
- Exposure of unerupted teeth .
- Pulpotomy .
- Treatment of aphthous ulcers .
- Excision of lesions ·
- Light activation of bleaching materials for teeth whitening •
The Fotona XPulse Laser System Family is a multi-application, multi-technology laser system family that supports the diode laser technology. A diode aiming beam is combined with all therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end. The Fotona XPulse Laser System Family consists of a console and a footswitch. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system micro-controller through an LCD touch-screen. A diode aiming beam is combined with all therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end. The following wavelengths are currently available with the XPulse System Family: 810 nm, 980 nm and 1064 nm. The following handpieces are to be used with Fotona XPulse Laser System Family: R21 (variants C2, C3, SHP and EHP), R26 (variants: black, green, blue, silver and red), Genova- and MarcCo (variants S, M and L).
The provided text is an FDA 510(k) clearance letter and associated summary for the Fotona XPulse Laser System Family. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than proving a medical device meets specific performance acceptance criteria through the kind of study described in the prompt.
Therefore, the information required to populate the fields related to acceptance criteria, test set, expert ground truth, adjudication, MRMC, standalone performance, training set, and ground truth establishment is not present in the provided text.
This document specifically states:
- "Clinical testing: No clinical testing was needed." (Page 11)
- The device's substantial equivalence is based on "technical characteristics, performance test data, and its intended use" compared to predicate devices, referencing adherence to various IEC and ISO standards for safety, electromagnetic compatibility, usability, and software (Pages 9-11). The "performance test data" mentioned here refers to engineering and quality assurance tests demonstrating the device's technical specifications match the predicate devices, not clinical studies for diagnostic accuracy or treatment efficacy.
In summary, the provided text does not contain the information requested in the prompt because the 510(k) pathway for this device did not require such a clinical study to demonstrate "acceptance criteria" and "device performance" in the way typically associated with diagnostic AI/ML products.
§ 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.