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510(k) Data Aggregation

    K Number
    K152141
    Device Name
    High Pressure Tanning Lamps
    Manufacturer
    BLV Licht-und Vakuumtechnik GmbH
    Date Cleared
    2016-02-25

    (206 days)

    Product Code
    LEJ
    Regulation Number
    878.4635
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    High Pressure Tanning Lamps

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

    This ultraviolet larop is intended for use in sunlamp products for tunning of the human skin

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a letter from the FDA regarding the clearance of "High Pressure Tanning Lamps" (K152141). This document does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications as typically found in a Section 510(k) summary or a clinical study report for AI/CAD devices.

    The document is purely an FDA clearance letter, confirming that the device is substantially equivalent to a predicate device for its stated indications for use (tanning human skin). It outlines regulatory requirements and contact information.

    Therefore, I cannot provide the requested information based on the given input.

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