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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.

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