BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LELO USA INC.

    Reg #: 3006317264 · FEI: 3006317264 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    18
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    LELO USA INC.
    Registration Number
    3006317264
    FEI Number
    3006317264
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    5799 Fontanoso Way
    City
    San Jose
    State
    CA
    ZIP
    95138
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160644

    Owner / Operator

    Firm Name
    Sedic
    Operator Number
    10036125
    Address
    5799 Fontanoso Way
    City
    San Jose
    State
    CA
    Postal Code
    95138
    Country
    US
    Correspondent
    Pavle Sedic

    Products

    Device Name Product Code
    Massager, Therapeutic, Electric ISA
    Condom HIS
    Device, External Penile Rigidity LKY
    Perineometer HIR
    Cup, Menstrual HHE

    Proprietary Names

    HEX Condoms Original 72 Pack (US_TNR) HEX Condoms Original 36 Pack (US_TNR) Lelo Hex Natural Rubber Latex Condom LELO HEX RE-ENGINEERED LATEX RESPECT CONDOM - 6 PACK HEX Condoms Original 3 Pack (US_TNR) HEX Condoms Original 12 Pack (US_TNR) LELO HEX RE-ENGINEERED LATEX CONDOM ORIGINAL - 6 PACK Banana Gold Lelo Hex Lubricated Natural Rubber Latex Condom 36’s Lelo Hex Lubricated Natural Rubber Latex Condom 3’s Lelo Hex Lubricated Natural Rubber Latex Condom Lelo Hex Lubricated Natural Rubber Latex Condom 12’s LELO RESPECT HEX Natural Rubber Latex Condom HEX Condoms Respect 3 Pack HEX Condoms Respect 36 Pack HEX Condoms Respect 12 Pack Ziggy Cup Lily Cup One

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device