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

    ARGON MICROSURIGAL PROTOCOLS

    K Number: K810740 · Decision Aug 21, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    23
    Applicant Total
    43
    Review Days
    155

    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
    ARGON MICROSURIGAL PROTOCOLS
    K Number
    K810740
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4500
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Lumenis, Inc.
    Date Received
    March 19, 1981
    Decision Date
    August 21, 1981
    Product Code
    EWG
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EWG Laser, Ent Microsurgical Carbon-Dioxide

    Similar 510(k) Clearances

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

    BENSON CCA100

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    LASERMATIC SURGILASER MODEL 5050

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ILLUMINA 55 CO2 LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ILLUMINA 40 CO2 LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ILLUMINA 25 CO2 LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all

    Other Clearances by Lumenis, Inc.

    K Number Device Name
    K211979 Lumenis Y&R Laser System
    K151109 Lumenis Smart532 Laser System
    K130195 SCANNING LASERLINK
    K111213 VISION ONE LASER SYSTEM
    K100228 VERSAPULSE MODEL P20 LASER SYSTEM
    K091962 POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200
    K082809 ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM
    K081704 SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS
    K053628 LIGHTSHEER DUET LASER SYSTEM
    K060338 FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO
    Search all 43 clearances from Lumenis, Inc. →