(72 days)
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue.
The GENTLEray 980 Diode Dental Laser System is intended for use in the following procedures: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flan Singgry, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.
The GENTLEray 980 Diode Dental Laser System is a portable instrument intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingiva) using a contact fiber optic delivery system.
The KaVo GENTLEray 980 Diode Dental Laser System's acceptance criteria and the study proving it meets these criteria are outlined through a comparison to predicate devices, focusing on technical specifications and intended use rather than direct performance metrics like sensitivity or specificity. This is a 510(k) submission, which primarily establishes substantial equivalence.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are the specifications of the predicate devices. The "reported device performance" is the specifications of the proposed device, demonstrating equivalence. There are no explicit quantitative performance metrics like sensitivity, specificity, or AUC provided in this document as it's a laser device for surgical procedures, not a diagnostic tool.
| Feature | Predicate Device (e.g., Biolitec Smilepro 980) | Proposed Device (KaVo GENTLEray 980) | Acceptance (Equivalence) |
|---|---|---|---|
| Technical Specifications | |||
| Wavelength | 980 nm | 980 nm | Met |
| Output Power | 15W | 12W | Similar (within range) |
| Power Range | 1-15W | 0.4 - 12W | Similar (within range) |
| Increments | 1W | 0.2 - 1W | Similar (within range) |
| Operating Modes | Pulsed or Continuous | Pulsed or Continuous | Met |
| Pulse Duration ON | 0.01 to 99.9 Sec. | 25μs to 99.9 Sec. | Similar (within range) |
| Pulse Duration OFF | 0.01 to 99.9 Sec. | 25μs to 99.9 Sec. | Similar (within range) |
| Frequency | 100 Hz | 20,000 Hz | Different, but considered acceptable for equivalence |
| Aiming beam | 635 nm, 4mW; Red | 635 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.