BEUDAMED
    FDA Enforcement Class II Terminated

    Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal, pigmented lesion removal, removal or lightening of hair, skin resurfacing and reduction of red pigmentation in hypertropic and keloid scars The two Multilite Dye Handpieces (HPs) are optional handpieces that can be used with the Revlite SI Laser. Manufactured by: ConBio, A Cynosure Company 47733 Fremont blvd Fremont, CA 94538

    Recall: Z-1599-2013 · Reported July 3, 2013

    Enforcement

    Recall Number
    Z-1599-2013
    Event ID
    65407
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ConBio, a CynoSure Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 3, 2013
    Initiation Date
    May 9, 2013
    Classification Date
    June 26, 2013
    Termination Date
    June 26, 2013
    Address
    47733 Fremont Blvd, Fremont, CA, 94538-6512, United States

    Description

    Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal, pigmented lesion removal, removal or lightening of hair, skin resurfacing and reduction of red pigmentation in hypertropic and keloid scars The two Multilite Dye Handpieces (HPs) are optional handpieces that can be used with the Revlite SI Laser. Manufactured by: ConBio, A Cynosure Company 47733 Fremont blvd Fremont, CA 94538

    Reason

    An inconsistency was identified related to electronic display identification of the optional Multilite Dye Handpieces of the RevLite SI Laser system that may confuse user.

    Code Info

    659-1050-585 nm Handpiece; Manufacturer numbers: 659-1050 / C13B1141 659-1050 / D13C1151 659-1050 / D13C1157 659-1050 / D13C1158 659-1050 / D13C1160 659-1050 / D13C1154 Model 659-1100 - 650 nm Handpiece; manufacturer numbers: 659-1100 / C13B1141 659-1100 / D13C1151 659-1100 / D13C1157 659-1100 / D13C1158 659-1100 / D13C1160 659-1100 / D13D1165.

    Distribution

    Worldwide distribution: USA (nationwide) including states of: IL, ME, NM and VA; and countries of: Australia and Chile.

    Quantity

    12 (6 of model 659-1050; 6 of model 659-1100)