(265 days)
810 nm Diode Laser System:
- · 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
- · Surgical applications requiring the ablation, vaporization, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, otolaryngology, ophthalmology, and pulmonology
810 nm Diode Laser Module:
· Incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following:
- 。 Gingival troughing for crown impression
- · Gingivoplasty
- · Soft tissue crown lengthening
- 。 Treatment of aphthous ulcers
- 。 Treatment of herpetic lesions
810 nm Diode Laser System & Module 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:
- · 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
· Surgical applications requiring the ablation, vaporization, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, and thoracic surgery.
445 nm Diode Laser:
· Incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue
The Fotona XPulse Pro Laser Platform is a multi-application, multi-technology platform 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 Pro Laser Platform consists of a console, a footswitch and attachable 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 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 platform: 445 nm, 810 mm and 980 nm.
Following handpieces are to be used with Fotona Xpulse Pro Laser Platform: R21-SHP, R26 (variants: black, green, blue, silver and red), R24, R30, Genova and MarcCo (variants S, M & L).
Please note: The provided text describes a medical device submission (510(k) Premarket Notification) for the Fotona XPulse Pro Laser Platform. This document focuses on demonstrating substantial equivalence to predicate devices and does not present a typical study with acceptance criteria and results in the way one might expect for a new diagnostic or AI-powered device.
Therefore, the requested information elements related to AI-specific study design (e.g., sample size for test sets, number of experts for ground truth, MRMC study, training set details) are not available in this document because this is a laser surgical instrument, not an AI diagnostic device. The document states "Clinical testing: No clinical testing was needed."
Here's the information that can be extracted from the provided text, structured to address your request where possible, and indicating where information is not applicable (N/A) or not provided:
Acceptance Criteria and Device Performance Study for Fotona XPulse Pro Laser Platform
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for a laser surgical instrument, and not an AI or diagnostic device with quantifiable performance metrics like sensitivity/specificity, the "acceptance criteria" are based on demonstrating substantial equivalence to existing predicate devices. The performance is assessed through technical specifications and adherence to standards rather than clinical endpoints in this 510(k) summary.
| Acceptance Criterion (Demonstrating Substantial Equivalence) | Reported Device Performance (Fotona XPulse Pro Laser Platform) |
|---|---|
| Identical or Similar Indications for Use | - 810 nm Diode Laser System: Incision, excision, vaporization, ablation, and coagulation of oral soft tissues; Periodontology (soft tissue curettage, removal of diseased tissue); Cosmetic Dentistry (bleaching/whitening); Implant recovery; Surgical applications in dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, pulmonology. |
- 810 nm Diode Laser Module: Incision, excision, vaporization, ablation, and coagulation of oral soft tissues (similar sub-indications as system).
- 810 nm Diode Laser System & Module in therapy: Temporary relief of minor muscle/joint pain, stiffness, arthritis pain, muscle spasm, sprains/strains, muscular back pain; temporary increase in local blood circulation; temporary relaxation of muscle.
- 980 nm Diode Laser: Gingival troughing, crown lengthening, gingivoplasty, coagulation, hemostasis of donor site, implant recovery/uncovery, soft tissue curettage, sulcular debridement, biopsy, frenectomy, operculectomy, exposure of unerupted teeth, pulpotomy, treatment of aphthous ulcers, excision of lesions, light activation for bleaching; Surgical applications in dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, thoracic surgery.
- 445 nm Diode Laser: Incision/excision, vaporization, ablation, hemostasis, and coagulation of soft tissue.
(These indications are explicitly stated as "same indications for use" with predicate devices in the Statement of Substantial Equivalence) |
| Similar Technological and Design Characteristics | - Energy Source: Diode (matches predicates) - Wavelengths: 810 nm, 980 nm, 445 nm (matches predicates)
- Power Output (Examples): Up to 8 W (810 nm system), Up to 1.5 W (810 nm module), Up to 12 W (980 nm), Up to 4 W (445 nm) (compared favorably to predicate ranges)
- Pulse Width (Examples): 20 μs to 30 s, CW (810 nm); 100 μs to 60 s, CW (980 nm) (similar to predicates, sometimes different ranges but functionally equivalent for intended use)
- Repetition Rate (Examples): CW, 0.1 Hz to 200 Hz (similar to predicates, sometimes different ranges but functionally equivalent)
- Delivery System: Contact and non-contact handpieces connected via fiber (matches predicates)
- User Interface: Touch screen control (matches most recent predicates)
- Aiming Beam: Laser diode (650 nm or 532 nm;
§ 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.