BEUDAMED
    FDA Enforcement Class II Terminated

    Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.

    Recall: Z-2973-2018 · Reported September 12, 2018

    Enforcement

    Recall Number
    Z-2973-2018
    Event ID
    80496
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Quasar Bio-Tech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 12, 2018
    Initiation Date
    June 29, 2018
    Classification Date
    September 5, 2018
    Termination Date
    August 27, 2019
    Address
    1465 Tallevast Rd, N/A, Sarasota, FL, 34243-5036, United States

    Description

    Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.

    Reason

    Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.

    Code Info

    Product Number DPA-023. UPC Code 0 91037 46144 5

    Distribution

    Nationwide distribution to CA, FL, GA, HI, IL, LA, MD, NE, NY, OH, TX, VA, WA, WI. Worldwide distribution to Australia, China, Netherlands, United Kingdom

    Quantity

    6,783 units total