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Bovie Medical Corporation Message Board

  • nc_gmbolser1 nc_gmbolser1 May 30, 2009 11:15 AM Flag

    510K: 90 Day Expectation

    The J-Plasma was filed on March 3rd 2009. There is a normal expectation of 90 days to receive clearance to market the device. Monday is the effective 90th day.

    Here's the link to the FDA 510K Description page.

    http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm#link_9

    Scroll to the end to find a normal 510K clearance expectation of 90 days for substantially equivalent (SE) devices. The J-Plasma is SE to the ARGON devices granted under the FDA classification code GEI.

    Here's a link to Valley Labs 510K GEI Classification ARGON device:

    http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062082.pdf


    ...and here is a link to Greg Konesky's Method Patent application for the J-Plasma (Greg already has a device patent).

    http://www.freepatentsonline.com/y2008/0108985.html?query=konesky%2C+gregory+a&stemming=on

    As you can see, the J-Plasma does the same things as the already cleared GEI Classification ARGON device––only the J-Plasma does these things with lower energy levels, superior adjustability and lower spurious patient currents (According to Konesky's patent claims.

    However, the J-Plasma does quite a bit more in that an ARRAY of plasma jets distributed through a 2X4" area applicator was discussed in Greg's recent scientific presentation in San Antonio, Texas. His talk was recorded and he used the term "Scrub Brush" to describe the J-Plasma. He also described dermatology as the "Low hanging fruit" for the initial market target.

    In brief:

    (1) we have a normal expectation of 90 days for an SE 510K application

    (2) the J-Plasma clearly appears to convey SE status with already approved GEI ARGON devices and

    (3) there are significant advantages to the J-Plasma device that do not require clinical trials because this is a Class !! device with SE to ARGON.

    +++++++++++++
    Recent Seeking Alpha articles suggesting six more months of 510K waiting for J-Plasma are not consistent with past BVX (GEI Classification) applications nor are these time estimates consistent with the FDA's own 510K guidelines NOR are they consistent with the substantial equivalence appearance with ARGON devices of the J-Plasma.

    This surprise article was at best misleading––Perhaps intentionally so.


    caio

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