BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118)

    K Number: K241443 · Decision Jan 21, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    242
    Applicant Total
    3
    Review Days
    244

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118)
    K Number
    K241443
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hathor Professional Skincare , Ltd.
    Date Received
    May 22, 2024
    Decision Date
    January 21, 2025
    Product Code
    NUC
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NUC Lubricant, Personal

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NUC), ordered by most recent decision date.

    PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    pjur NATURE Touch, 100 ml

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Julva Velvé Water-Based Personal Lubricant

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Water-based lubricant

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Hathor Professional Skincare , Ltd.

    K Number Device Name
    K252914 Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)
    K250629 Sutil Rich Personal Lubricant