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510(k) Data Aggregation

    K Number
    K033259
    Manufacturer
    Date Cleared
    2004-02-25

    (139 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    LIGHT AGE Q-CLEAR LASER, MODEL 701-1101

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

    The Light Age Q-Clear™ Laser is indicated for the following uses:

    1. For incision, excision, ablation, and vaporization of soft tissue for General Dermatology
    2. The 1064nm wavelength is indicated for:
    • Dark ink tattoo removal
    • Removal of pigmented lesions (particularly Nevus of Ota)
    • Removal or lightening of hair
    • Skin resurfacing with or without adjuvant preparation
    • Treatment of common nevi
    1. The 532nm wavelength is indicated for:
    • Removal of light ink (red, tan, purple and orange) tattoos
    • Treatment of common nevi
    • Treatment of café-au-lait spots
    • Treatment of seborrheic keratoses
    • Treatment of vascular lesions, including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, and ephelides)
    Device Description

    The Light Age Q-Clear™ Laser has a Nd: Y AG crystal rod as a lasing medium. Pulsed energy is emitted at 1064 nanometers in the near-infrared portion of the spectrum. With the optional frequency doubler installed, a 532nm beam is emitted. The laser is delivered directly to the target area via the handpiece, which produces a circular beam on the skin. A red aiming beam is provided to allow the operator to precisely target the treatment area. The Q-Clear™ Laser is equipped with safety features in conformance with 21CFR Part 1040.

    AI/ML Overview

    The provided text is a 510(k) summary for the Light Age Q-Clear™ Laser. It details the device's description, intended use, and claims of substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

    The document is a regulatory submission for premarket notification, asserting that the device is "substantially equivalent" to previously cleared devices. This type of submission often relies on demonstrating that the new device has the same technological characteristics and intended use as predicate devices, and does not raise new questions of safety or efficacy. It generally does not include detailed performance studies with acceptance criteria in the way a clinical trial or a specific analytical performance study for a diagnostic device would.

    Therefore, I cannot provide the requested information from the provided text.

    Specifically, the following information is not available in the provided document:

    1. A table of acceptance criteria and the reported device performance: This document asserts substantial equivalence, not specific performance metrics against defined acceptance criteria.
    2. Sample size used for the test set and the data provenance: No performance study is described that would have a test set.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth for a test set is described.
    4. Adjudication method for the test set: Not applicable.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
    6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a laser device, not an algorithm.
    7. The type of ground truth used: Not applicable.
    8. The sample size for the training set: Not applicable.
    9. How the ground truth for the training set was established: Not applicable.

    The document's statement regarding safety and effectiveness is: "The Light Age Q-Clear™ Laser has the same wavelengths, the same spot size, the same Frie Light of operation, essentially the same fluence levels, and the same intended use as the predicate devices. The Light Age Q-Clear™ Laser does not raise new questions of safety or efficacy, and is substantially equivalent to the predicate devices." This is the core argument for its approval, not a report of meeting specific performance criteria from a new study.

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