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510(k) Data Aggregation

    K Number
    K082825
    Manufacturer
    Date Cleared
    2009-02-06

    (134 days)

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

    ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM

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

    The Energist ULTRA™ VPL Intense Pulsed Light System is intended for permanent hair reduction and the treatment of mild to moderate inflammatory Acne Vulgaris. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the treatment of benign pigmented lesions.

    • Intense Pulsed Light Energy / wavelengths (530 950nm) .
      The 530 - 950nm intense pulsed wavelengths are indicated for: The treatment of mild to moderate inflammatory Acne Vulgaris. The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae.

    The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, Poikiloderma of Civatte, leg veins, facial veins and venous malformations.

    Intense Pulsed Light Energy / wavelengths (610 - 950nm)

    The 610 - 950nm intense pulsed wavelengths are indicated for: The removal of unwanted hair from all skin types and to effect stable longterm or permanent " hair reduction in skin types I - V through selective targeting of melanin in hair follicles.

    • Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.

    Intense Pulsed Light Energy/wavelengths (415/630 - 950nm) 1 The treatment of mild to moderate inflammatory Acne Vulgaris.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer. It primarily discusses the regulatory approval of the Energist ULTRAPLUS™ VPL Intense Pulsed Light System and lists its indications for use.

    This document does not contain information about specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies as requested in your prompt. Therefore, I cannot extract the requested information from this text.

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