BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SHARKNINJA OPERATING LLC

    Reg #: 3013738756 · FEI: 3013738756 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    SHARKNINJA OPERATING LLC
    Registration Number
    3013738756
    FEI Number
    3013738756
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    89 A St #100
    City
    Needham
    State
    MA
    ZIP
    02494
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242796

    Owner / Operator

    Firm Name
    SharkNinja Operating LLC
    Operator Number
    10092175
    Address
    89 A St #100
    City
    Needham
    State
    MA
    Postal Code
    02494
    Country
    US
    Correspondent
    Adam Johnson

    Products

    Device Name Product Code
    Over-The-Counter Powered Light Based Laser For Acne OLP
    Light Based Over The Counter Wrinkle Reduction OHS
    Pack, Hot Or Cold, Reusable IME
    Pad, Heating, Powered IRT

    Proprietary Names

    CryoGlow ChillPill (UH025) Shark FacialPro Glow (FH3XXX) Shark Depuffi (FH2XX) Shark FacialPro Glow (FH3XX)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198