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510(k) Data Aggregation

    K Number
    K260765

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-10

    (1 days)

    Product Code
    Regulation Number
    878.4810
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Dental Soft Tissue Indications

    Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:

    • Excisional and incisional biopsies
    • Exposure of unerupted teeth
    • Fibroma removal
    • Frenectomy
    • Frenotomy
    • Gingival troughing for crown impressions
    • Gingivectomy
    • Gingivoplasty
    • Gingival incision and excision
    • Hemostasis and coagulation
    • Implant recovery
    • Incision and drainage of abscess
    • Leukoplakia
    • Operculectomy
    • Oral papillectomies
    • Pulpotomy
    • Pulpotomy as an adjunct to root canal therapy
    • Reduction of gingival hypertrophy
    • Soft tissue crown lengthening
    • Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
    • Treatment of aphthous ulcers
    • Vestibuloplasty
    • Tissue retraction for impression
    • Lesion (tumor) removal

    Laser Periodontal Procedures

    • Laser soft tissue curettage
    • Laser removal of diseased, Infected, Inflamed and necrosed soft tissue within the periodontal pocket
    • Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium
    • Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
    • Reduction of bacterial level (decontamination) and inflammation

    Pain therapy

    • Topical heating for the purpose of elevating tissue temperature for a 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.
    Device Description

    The Gemini Nova 810 + 980 Soft Tissue Laser is a dual-wavelength diode laser system delivering 810 nm and 980 nm laser energy for oral soft-tissue procedures. Laser energy is delivered through fiber-optic disposable tips or photobiomodulation (PBM) adapters. The system includes a base unit, wand, wireless foot pedal, and rechargeable battery packs.

    AI/ML Overview

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