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510(k) Data Aggregation

    K Number
    K252048

    Validate with FDA (Live)

    Date Cleared
    2026-02-03

    (218 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K220381

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

    The 808nm Semiconductor laser hair removal machine is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

    Device Description

    This 808nm semiconductor laser hair removal machine adopts 808nm semi-conductor laser, based on selective photothermolysis principle, through specific wavelength, penetrate epidermis into dermis, optical energy was absorbed and translated into heat energy with restraining hair follicle tissues, and produce photothermal effect. It takes laser energy in hair follicle with rich in melanin, surrounding tissues absorb less even no energy, reach to restrained melanin of hair follicles and remove hair. The Medical Diode Laser Hair Removal System utilize a semiconductor diode with invisible infrared radiation as a laser source to emit 808nm wavelength laser which is absorbed by melanin. The laser power is delivered to the treatment area via laser handpiece. The emission laser is activated by a foot-switch.

    This 808nm semiconductor laser hair removal machine consists of laser power supply, laser treatment handle, host controller, liquid crystal controller (operating system) water cooling system, low voltage control circuit and fault alarm system. Accessories include water filling funnel, overflow plug, foot switch, bracket, key, laser protection goggles (operator wearing), protective eye wear (patient wearing), power line, fuse, user manual and packing list.

    AI/ML Overview

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