Device Recall Dermonosonic NonInvasive Subdermal Therapy System

  • Model / Serial
    serial numbers: 8, 960, 1341, 1343, 1344, 1351 through 1354, 1359, 1363, 1365 through 1368, 1372,  1379, 1581, 1583, 1584, 1589 through 1593, 1598, 1599, 1756, 1757, 1760, 1771,  1784, 1786, 1792, 1793, 2001, 2005, 2007, 2012 through 2018, 2020 through 2025, 2028, 2029, 2031, 2032, 2036, 2037, 2038, 2041, 2043, 2044, 2047,  2175, 2176, 2177, 2180 through 2187, 2189 through 2195, 2197, 2198, 2348, 2355 through 2370, 2372, 2373, 2374, 2375, 2376, 2378, 2381, 2382,  2389, 2390, 2392, 2393, 2400 through 2433, 2435, 2436, 2442, 2443, 2453, 2475, 2560,  2562, 2563, 2564, 2565, 2566, 2568, 2569, 2572 through 2579, 2590, 2592, 2593, 2595, 2596, 2597, 2598, and 2599
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AZ, CA, CO, CT, FL, GA, ID, IL, IA, KS, LA, MA, MI, MN, NV, NJ, NM, NY, NC, OH, OK, OR, SC, SD, TN, TX, UT, VA & WI and to the Phillipines
  • Product Description
    Dermosonic Model 430300 and 440100 Non-Invasive Subdermal Therapy System
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Sybaritic, Inc, 9220 James Ave S, Bloomington MN 55431-2302
  • Source
    USFDA