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510(k) Data Aggregation

    K Number
    K060787
    Device Name
    TATTOOSTAR FAMILY
    Manufacturer
    ASCLEPION LASER TECHNOLOGIES GMBH
    Date Cleared
    2006-09-27

    (188 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TATTOOSTAR FAMILY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TattooStar R is intended for use for cutting, vaporization and ablation of soft tissue and the removal of tattoos and benign pigment lesion.

    Some examples of pigment lesions are:

    Lentigines, Café-au-lait-blotches, Ephalides, BenignNaevi such as Naevus of Ota, Naevus of Ito, Epidermal Naevi, Congenital Naevi, Beckers Naevi, Blue Nevus, Naevus Spillus and Mongolian Spot.

    Device Description

    The TattooStar R is a q-switched solid state lasers emitting wavelengths of 694 nm (Rubylaser). It consists a laser enclosure and optic delivery system (articulated mirror arm).

    AI/ML Overview

    This 510(k) premarket notification for the TattooStar R device indicates that no nonclinical or clinical performance data was provided or required to demonstrate substantial equivalence.

    Therefore, the following information cannot be extracted from the provided text:

    • Acceptance criteria and reported device performance: No criteria were outlined, and no performance data was presented.
    • Sample size and data provenance for the test set: No test set was used.
    • Number of experts and their qualifications: No experts were involved in establishing ground truth for a test set.
    • Adjudication method: Not applicable as there was no test set or expert review.
    • MRMC comparative effectiveness study: Not conducted.
    • Standalone performance study: Not conducted.
    • Type of ground truth used: Not applicable as no ground truth was established for performance evaluation.
    • Sample size for the training set: Not applicable as the device's performance was not evaluated through a training set.
    • How ground truth for the training set was established: Not applicable.

    The FDA's decision to clear the device was based on its substantial equivalence to a previously legally marketed predicate device, the RubyStar. This means the FDA determined that the TattooStar R has the same intended use, similar technological characteristics (same principle of operation, same wavelength), and raises no new questions of safety or effectiveness compared to the RubyStar, even though the RubyStar has a long-pulsed mode not present in the TattooStar R.

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