BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    REVIAN LYTE

    Reg #: 3013387006 · FEI: 3013387006 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OPULENT SOLUTIONS SDN.BHD.
    Registration Number
    3013387006
    FEI Number
    3013387006
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Plot 111, Bayan Lepas Industrial Park, Lebuh Raya Kampung Jawa
    City
    Bayan Lepas Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K242441

    Owner / Operator

    Firm Name
    Opulent Solutions Sdn.Bhd.
    Operator Number
    10059914
    Address
    Plot 111, Bayan Lepas Industrial Park, Lebuh Raya Kampung Jawa
    City
    Bayan Lepas
    State
    Pulau Pinang
    Postal Code
    11900
    Country
    MY

    US Agent

    Business Name
    REVIAN, Inc
    Contact Name
    Tammy Carrea
    Address
    615 Davis Drive Suite 800,, MORRISVILLE , NORTH CAROLINA , 27560 , UNITED STATES
    City
    Morrisville
    State
    NC
    ZIP
    27560
    Country
    US
    Email
    [email protected]
    Phone
    919 9315602

    Products

    Device Name Product Code
    Laser, Comb, Hair OAP

    Proprietary Names

    REVIAN LYTE

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)