BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇱🇺 Luxembourg

    pjur NATURE Touch, 100 ml

    K Number: K260068 · Decision May 21, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    242
    Applicant Total
    7
    Review Days
    132

    Basic Information

    Device Name
    pjur NATURE Touch, 100 ml
    K Number
    K260068
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pjur Group Luxembourg S.A.
    Date Received
    January 9, 2026
    Decision Date
    May 21, 2026
    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

    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

    Chiavaye Personal Moisturizer

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

    Other Clearances by Pjur Group Luxembourg S.A.

    K Number Device Name
    K200527 pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur
    K200731 pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5
    K200730 pjur WOMAN Nude pjur med SENSITIVE glide
    K141913 PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME!
    K133336 PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE
    K133233 PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE