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FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K214078Silk’n ToothwaveJanuary 13, 2023
DEN190039ToothWave™September 17, 2020
K180279Silk'n MODEL H5003 deviceMay 9, 2018
K171433Silk'n InfinityAugust 11, 2017
K162784Silk'n HSTMarch 25, 2017
K152087HeatLux Pro IIJuly 29, 2016
K150175HeatLux Pro IMarch 31, 2015
K141242GLIDE DEVICEOctober 17, 2014
K131870GLIDE DEVICEAugust 14, 2013
K121435SILKN BLUEFebruary 22, 2013
K120582HEATLUXJuly 6, 2012
K110301SILK'N FXAugust 19, 2011
K103184SILK'N FLASH N GONovember 10, 2010
K082298FLASH N' GOOctober 23, 2008
K072906SILK'NJanuary 23, 2008