BEUDAMED
    Product Code: OLI FDA class 2 21 CFR 878.5400

    Fat Reducing Low Level Laser

    General, Plastic Surgery

    The Fat Reducing Low Level Laser (product code OLI) is a Class 2 device regulated under 21 CFR 878.5400 in the General, Plastic Surgery specialty (SU), cleared via 510(k). It is indicated for the non-invasive reduction of the subcutaneous fat layer for body contouring purposes. The device is eligible for third-party review and is not an implant or life-sustaining device.

    View on FDA
    510(k)s
    33
    FEI Numbers
    15
    Registration Numbers
    15
    Unique Applicants
    15
    Years Active
    16

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    Basic Information

    Product Code
    OLI
    Device Class
    FDA class 2
    Regulation Number
    878.5400
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Non-invasive reduction in fat layer for body contouring

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 33 510(k) clearances via K numbers.

    K Number Device Name
    K260688 Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)
    K260129 Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )
    K243854 Contour Light (CL-100)
    K252574 Erchonia CLX (Model # CFL)
    K252786 Led Light Phototherapy Bed (Pro 450/ GY-680A)
    K243811 Erchonia Zerona® VZ8
    K232977 Biophotas Celluma CONTOUR
    K231474 Erchonia Violet ZERONA® Z6 OTC
    K220519 Erchonia Zerona Z-Bed
    K213534 PHantom Trilogy
    K202955 Contour Light CL-100
    K202361 UltraSlim Digital, UltraSmooth Digital
    K192275 invisa-RED ELITE
    K192544 Erchonia Emerald
    K180338 Cellulize
    K172111 Vevazz LED
    K170709 CURVE Laser System
    K162578 Zerona Z6 OTC
    K160880 Photonica Professional
    K150446 Erchonia Zerona 6 headed scanner EZ6
    K143741 Lipofina Laser System
    K143007 Erchonia Zerona Z6 OTC
    K142042 ERCHONIA SHL
    K134040 BTL-9000; BTL-9000 RADIOFREQUENCY MODULE
    K133718 ZERONA
    K130341 STRAWBERRY, STRAWBERRY & CREAM
    K130922 ERCHONIA VERJU LASER SYSTEM WITH MASSAGER
    K123237 ZERONA 2.0 LASER
    K121695 ERCHONIA ZERONA
    K121690 ETCHONIA ZERONA ARMS
    K120257 MLS, ZERONA-AD
    K111501 I-LIPO SYSTEM
    DEN090008 ERCHONIA ML SCANNER (MLS)

    FEI Numbers

    This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.