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

    PORTALASE 200 CARBON SURGICAL LASER SYSTEM

    K Number: K852694 · Decision Sep 30, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    47
    Applicant Total
    12
    Review Days
    96

    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
    PORTALASE 200 CARBON SURGICAL LASER SYSTEM
    K Number
    K852694
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4550
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Minnesota Laser Corp.
    Date Received
    June 26, 1985
    Decision Date
    September 30, 1985
    Product Code
    HHR
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HHR Laser, Surgical, Gynecologic

    Similar 510(k) Clearances

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

    ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MODEL 5050 SURGILASER FOR OB-GYN USE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    GL-35 COLPOSCOPIC LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    LASER CANNISTER FILTER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Minnesota Laser Corp.

    K Number Device Name
    K874255 ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.
    K874253 ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.
    K874254 ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS
    K854473 PORTALASE 300 CARBON DIOXIDE SURG LASER NEUROLOGIC
    K854468 PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC
    K854471 PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T
    K854472 PORTALASE 300 CARBON DIOXIDE SURG LASER DERMATOLOG
    K854469 PORTALASE 200 CARBON DIOXIDE SURG LASER DERMATOLOG
    K854470 PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI
    K852696 FOR USE IN GENERAL & PLASTIC SURGERY & DERMATOLOGY
    Search all 12 clearances from Minnesota Laser Corp. →