BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM

    K Number: K124043 · Decision Sep 26, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    62
    Same Product Code
    176
    Applicant Total
    9
    Review Days
    272

    Basic Information

    Device Name
    LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM
    K Number
    K124043
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    LIGHTMED CORP.
    Date Received
    December 28, 2012
    Decision Date
    September 26, 2013
    Product Code
    HQF
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HQF Laser, Ophthalmic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HQF), ordered by most recent decision date.

    EyeQ nanoECP

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Leos Laser and Endoscopy System

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LYNX Photocoagulator

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VISULAS combi

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MR Q; MR Q SUPINE; MR Q SLT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Eagle device

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all

    Other Clearances by LIGHTMED CORP.

    K Number Device Name
    K142172 LIGHTMED TRUSCAN 577
    K103547 LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM
    K091981 LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER
    K091534 LIGHTLAS MODEL 532
    K090774 LIGHTLAS SELECTOR
    K063297 LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR
    K021538 LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR
    K010372 LIGHTLAS 532 PHOTOCOAGULATOR