BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇰🇷 South Korea

    Dr’s Finder NEO

    K Number: K171867 · Decision Mar 30, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    7
    Review Days
    281

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    Basic Information

    Device Name
    Dr’s Finder NEO
    K Number
    K171867
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Good Doctors Co., Ltd.
    Date Received
    June 22, 2017
    Decision Date
    March 30, 2018
    Product Code
    LQY
    Advisory Committee
    Unknown
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LQY Locator, Root Apex

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    Other Clearances by Good Doctors Co., Ltd.

    K Number Device Name
    K223507 CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)
    K183471 IC-WHCD100 (Inspire)
    K173157 Dr's Light2
    K151274 Dr's Finder
    K093751 CL-DC20, CL-DC21
    K071908 DOCTOR'S LIGHT LED DENTAL CURING LIGHT