BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR

    K Number: K140782 · Decision Aug 13, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    8
    Applicant Total
    3
    Review Days
    135

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR
    K Number
    K140782
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4410
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Celleration, Inc.
    Date Received
    March 31, 2014
    Decision Date
    August 13, 2014
    Product Code
    NRB
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NRB Wound Cleaner, Ultrasound

    Similar 510(k) Clearances

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

    Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AS 1000 ULTRASOUND WOUND THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Celleration, Inc.

    K Number Device Name
    K122246 MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12
    K050129 CELLERATION MIST THERAPY SYSTEM 5.1