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Devices
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
Physical Medicine Devices
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
Sybaritic, Inc
1 Event
Recall of Device Recall Dermonosonic NonInvasive Subdermal Therapy System
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Manufacturer
Sybaritic, Inc
Manufacturer Address
Sybaritic, Inc, 9220 James Ave S, Bloomington MN 55431-2302
Source
USFDA
Language
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