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Sciton, Inc

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251077JOULE 1064nm System and AccessoriesDecember 19, 2025
K222958mJOULE RF System and AccessoriesApril 23, 2024
K213761Joule diVa SystemJuly 19, 2022
K213350mJOULE System and AccessoriesApril 15, 2022
K182173Joule SystemMarch 6, 2019
K180508JOULE SYSTEMMay 18, 2018
K173285JOULE SYSTEMJanuary 29, 2018
K122567JOULE 810/940/980 MULTI-PLATFORM SYSTEMJune 19, 2013
K111483JOULE CLEARSENSE LASER SYSTEMDecember 7, 2011
K101916JOULE MULTI-PLATFORM SYSTEMMarch 18, 2011
K081352PROFILE MULTI-PLATFORM SYSTEMOctober 23, 2008
K070388PROFILE MULTI-PLATFORM SYSTEMMay 2, 2007
K060033PROFILE MULTI-PLATFORM SYSTEMFebruary 28, 2006
K040005PROFILE 2000/3000 LASER SYSTEMMarch 29, 2004
K032459PROFILE 1320 LASER SYSTEMMarch 9, 2004
K032460PROFILE BBL SYSTEMNovember 13, 2003
K023881PROFILE 1064 LASER SYSTEMJune 13, 2003
K022466PROFILE 1320 LASER SYSTEMDecember 31, 2002
K022381PROFILE 1320 LASER SYSTEMOctober 18, 2002
K012552SCITON IMAGE HAIR REMOVAL LASERNovember 5, 2001