BEUDAMED
    Product Code: ONG FDA class 2 21 CFR 878.4810

    Powered Laser Surgical Instrument With MicrobeamFractional Output

    General, Plastic Surgery

    The Powered Laser Surgical Instrument With Microbeam Fractional Output (product code ONG) is a Class 2 surgical device regulated under 21 CFR 878.4810 in the General, Plastic Surgery specialty (SU), cleared via 510(k). It is a LASER-based device that delivers coherent, collimated, typically monochromatic radiation in the form of tiny microbeams, typically indicated for destroying, removing, or coagulating soft tissue in plastic surgery, general surgery, and dermatology/aesthetic specialties. 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
    60
    Registration Numbers
    60
    Unique Applicants
    26
    Years Active
    16

    Basic Information

    Product Code
    ONG
    Device Class
    FDA class 2
    Regulation Number
    878.4810
    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

    A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. The laser output is in form of tiny beams in micro range. Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic to destroy, remove or coagulate tissue, generally soft tissue. Indication for Use can be general and/or specific. The classification regulation 21 CFR 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.

    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
    K251031 Fiber Laser Treatment Systems (HS-232,HS-233)
    K250402 AVAVA™ Skin Treatment System
    K233550 MOSAIC 3D (Surgical Laser)
    K223871 Miria Skin Treatment System
    K221268 SR-1 Skin Treatment System
    K221770 Fiber Laser Treatment System
    K213332 Multifrax Laser System
    K202884 SR-1 Skin Treatment System
    K192350 Medical Non-Ablative Fractional Laser Systems
    K182498 Advanced Skin Renewing Device
    K180036 SMAXEL CO2 Surgical Laser System
    K162398 CO2 Laser Therapy Systems
    K141868 TRIA FANP
    K141046 MIDI-SRS
    K130459 TRIA FAN SYSTEM
    K131903 EQUINOX CO2 LASER
    K130028 RESURFX 1565NM LASER MODULE
    K110333 NATURALASE CO2 LASER SYSTEM
    K120433 CLEAR + BRILLIANT LASER SYSTEM
    K111831 MX-7000 MICROXEL
    K111840 EMERGE FRACTIONAL LASER
    K110984 SLIM E30 II CO2 LASER
    K110349 CLEAR+BRILLIANT LASER SYSTEM
    K103664 PRIMUS AESTHETIC PLATFORM
    K100610 LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS
    K100487 EQUINOX CO2 LASER SYSTEM
    K100590 EDGE CO2 LASER SYSTEM
    K101490 FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US
    K101506 LUX1540, LUX1440 & LUX2940 LASER HANDPIECES
    K090639 EXELO2, MODEL 4010
    K091446 MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE
    K091420 FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500
    K090525 LOI SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 60 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 60 registration numbers. Click on an entry to view related FDA registrations.