BEUDAMED
    Product Code: OHV FDA class 2 21 CFR 878.4590

    Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

    General, Plastic Surgery

    The Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption is a non-invasive aesthetic device that uses focused ultrasound to produce localized mechanical motion within tissues and cells, resulting in either tissue coagulation through localized heating or mechanical disruption of cellular membranes. Classified as FDA Class 2 under regulation 21 CFR 878.4590 within the General, Plastic Surgery medical specialty, it requires a 510(k) premarket notification. The product code is OHV. It is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    30
    FEI Numbers
    15
    Registration Numbers
    15
    Unique Applicants
    7
    Years Active
    17

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    Basic Information

    Product Code
    OHV
    Device Class
    FDA class 2
    Regulation Number
    878.4590
    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 device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for non-invasive aesthetic use.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 30 510(k) clearances via K numbers.

    K Number Device Name
    K260618 Ulthera® System
    K250418 Ulthera System (UC-1 Control Unit PRIME Model 2.1)
    K243035 Ulthera® System
    K240687 SofWave System
    K233996 Ulthera System (UC-1 Control Unit PRIME)
    K233104 SofWave System
    K232455 SofWave System
    K230100 SCIZER (SC1-M410)
    K231628 BeShape One™ Device
    K231537 SofWave System
    K230820 SofWave System
    K230019 SofWave System
    K223237 SofWave System
    K211483 SofWave System
    K181896 LIPOcel
    K191421 Sofacia System
    K180623 Ulthera System
    K170370 ULTRASHAPE POWER SYSTEM
    K162163 UltraShape System
    K161952 UltraShape System
    K160896 ULTRASHAPE POWER SYSTEM
    K141708 ULTRASHAPE SYSTEM
    K134032 ULTHERA SYSTEM
    K133238 CONTOUR I V3.1 SYSTEM
    K132028 ULTHERA SYSTEM
    K121700 ULTHERA SYSTEM
    K122528 ULTHERA SYSTEM
    K112626 LIPSONIX(R) SYSTEM MODEL 2
    K100874 LIPOSONIX SYSTEM, MODEL 1 P00XXXX
    DEN080006 ULTHERA SYSTEM, MODEL 8850-0001

    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.