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510(k) Data Aggregation

    K Number
    K254271

    Validate with FDA (Live)

    Device Name
    CAPRI
    Manufacturer
    ORO Co., Ltd.
    Date Cleared
    2026-02-26

    (58 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K041242
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CAPRI is indicated for use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue,

    • Treatment of back acne
    • Treatment of atrophic acne scars
    • Treatment of facial wrinkles
    • Treatment of mild to moderate acne vulgaris
    • Treatment of Sebaceous Hyperplasia.
    Device Description

    CAPRI is a diode laser which delivers energy at a wavelength of 1450 nm and it is indicated for use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue. Laser energy is delivered through an optical fiber that is attached to the handpiece. Laser guide tip is attached to the handpiece ensures that the spot is focused on the skin and serves as the laser beam aiming device.

    CAPRI consists of the following components:

    • Main Unit
    • Accessories:
      • Handpiece & Laser Guide Tip
      • Foot Switch
      • Remote Interlock Connector
      • Gas Spray (HFC-134)
      • Key Switch
      • Eye Protection Goggle
    AI/ML Overview

    N/A

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