BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Passiflora inc.

    Reg #: 3020659203 · FEI: 3020659203 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    5

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    Registration Details

    Registration Name
    Passiflora inc.
    Registration Number
    3020659203
    FEI Number
    3020659203
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    Passiflora Inc., 1000 5th Street Suite 200
    City
    Miami Beach
    State
    FL
    ZIP
    33139
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223595

    Owner / Operator

    Firm Name
    Passiflora Inc
    Operator Number
    10061598
    Address
    Passiflora Inc., 1000 5th Street Suite 200
    City
    Miami Beach
    State
    FL
    Postal Code
    33139
    Country
    US
    Correspondent
    Moran S Tabak

    Products

    Device Name Product Code
    Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation QRC
    Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction PAY
    Over-The-Counter Powered Light Based Laser For Acne OLP
    Lamp, Infrared, Therapeutic Heating ILY
    Light Based Over The Counter Wrinkle Reduction OHS

    Proprietary Names

    In2 Patch Tripollar Device Zutta LED Mask

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device