Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K252599

    Validate with FDA (Live)

    Date Cleared
    2026-02-24

    (190 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Diode Laser Therapy Systems is intended for use in dermatological procedures requiring coagulation.

    Indications for Use:

    Mixed Wavelength Handpiece (755 nm + 808 nm + 1064 nm):

    • Temporary hair reduction (Hair-Removal function).
    • Treatment of benign vascular and vascular-dependent lesions (Vascular-Lesion function).

    Single Wavelength Handpieces (755 nm, 808 nm, or 1064 nm):

    • Hair removal and permanent hair reduction in all skin types (Fitzpatrick skin types I-VI).

    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 completion of a treatment regimen.

    Device Description

    The Diode Laser Therapy Systems, Model WLA-02, is a medical device intended for dermatological procedures requiring coagulation. It includes mixed and single wavelength handpieces designed for temporary and permanent hair reduction, as well as the treatment of benign vascular lesions. The system delivers controlled laser energy to target melanin or vascular structures while integrated cooling helps protect surrounding skin tissue. The system comprises:

    • Main Console: Includes power switch, handpiece holder, LCD touch screen, emergency shut-off, hand-grip grab bar, handpiece connector, access door, observation window, power input, inlet, air switch, gate interlock connector, foot switch connector, vent, drain, and cooling fans.
    • Treatment Handpiece: Incorporates laser aperture, laser emission indicator, laser emission system, and handpiece display screen.
    • Foot Switch: Activates laser emission.
    • Embedded Software: Diode Laser Therapy Systems Control Software.
    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1