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510(k) Data Aggregation

    K Number
    K040055
    Device Name
    POLYLASE LP
    Manufacturer
    DDC TECHNOLOGIES, INC.
    Date Cleared
    2004-04-07

    (86 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    DDC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - The POLYLASE LP PULSED DUAL OUTPUT LASER is intended to effect 1. TEMPORARY HAIR REDUCTION in skin types I-IV with 755 nm output wavelength) and skin types IV-VI with 1064 nm output wavelength. - 2. The POLYLASE LP PULSED DUAL OUTPUT LASER is also intended to effect STABLE LONG-TERM, OR PERMANENT, HAIR REDUCTION in skin types I-III with use of 755 nm wavelength and skin types IV and V with use of 1064 nm wavelength through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen. - 3. FOR PHOTOCOAGULATION AND HEMOSTASIS OF DERMATOLOGICAL VASCULAR LESIONS with 1064 nm output wavelength. - 4. FOR INCISION/EXCISION OF SOFT BODY TISSUES IN DERMATOLOGY with 1064 nm output wavelength. - 5. FOR NONABLATIVE WRINKLE REDUCTION AND SKIN COLLAGEN REJUVENATION with 1064 nm output wayelongth
    Device Description
    Not Found
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    K Number
    K020513
    Device Name
    EPY-50
    Manufacturer
    DDC TECHNOLOGIES, INC.
    Date Cleared
    2002-05-16

    (90 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    DDC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. The EPY-50 PULSED Nd: YAG LASER is intended to effect TEMPORARY HAIR REDUCTION in skin types I-IV. 2. The EPY-50 PULSED Nd: YAG LASER is also intended to effect STABLE LONG-TERM, OR PERMANENT, HAIR REDUCTION in skin types I-IV through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen. 3. VASCULAR LESIONS.
    Device Description
    Not Found
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    K Number
    K010715
    Device Name
    AL-40
    Manufacturer
    DDC TECHNOLOGIES, INC.
    Date Cleared
    2001-10-04

    (209 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    DDC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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