Medical Device Manufacturer · US , Palo Alto , CA

Sciton, Inc - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 2000
23
Total
23
Cleared
0
Denied

FDA 510(k) cleared devices by Sciton, Inc General & Plastic Surgery

23 devices
1-23 of 23
Cleared Dec 19, 2025
JOULE 1064nm System and Accessories
K251077 · GEX
General & Plastic Surgery · 255d
Cleared Apr 23, 2024
mJOULE RF System and Accessories
K222958 · GEI
General & Plastic Surgery · 574d
Cleared Jul 19, 2022
Joule diVa System
K213761 · GEX
General & Plastic Surgery · 230d
Cleared Apr 15, 2022
mJOULE System and Accessories
K213350 · GEX
General & Plastic Surgery · 189d
Cleared Mar 06, 2019
Joule System
K182173 · GEX
General & Plastic Surgery · 208d
Cleared May 18, 2018
JOULE SYSTEM
K180508 · GEX
General & Plastic Surgery · 81d
Cleared Jan 29, 2018
JOULE SYSTEM
K173285 · GEX
General & Plastic Surgery · 105d
Cleared Jun 19, 2013
JOULE 810/940/980 MULTI-PLATFORM SYSTEM
K122567 · GEX
General & Plastic Surgery · 300d
Cleared Dec 07, 2011
JOULE CLEARSENSE LASER SYSTEM
K111483 · PDZ
General & Plastic Surgery · 190d
Cleared Mar 18, 2011
JOULE MULTI-PLATFORM SYSTEM
K101916 · GEX
General & Plastic Surgery · 252d
Cleared Oct 23, 2008
PROFILE MULTI-PLATFORM SYSTEM
K081352 · GEX
General & Plastic Surgery · 162d
Cleared May 02, 2007
PROFILE MULTI-PLATFORM SYSTEM
K070388 · GEX
General & Plastic Surgery · 82d
Cleared Feb 28, 2006
PROFILE MULTI-PLATFORM SYSTEM
K060033 · GEX
General & Plastic Surgery · 54d
Cleared Mar 29, 2004
PROFILE 2000/3000 LASER SYSTEM
K040005 · GEX
General & Plastic Surgery · 87d
Cleared Mar 09, 2004
PROFILE 1320 LASER SYSTEM
K032459 · GEX
General & Plastic Surgery · 211d
Cleared Nov 13, 2003
PROFILE BBL SYSTEM
K032460 · GEX
General & Plastic Surgery · 94d
Cleared Jun 13, 2003
PROFILE 1064 LASER SYSTEM
K023881 · GEX
General & Plastic Surgery · 204d
Cleared Dec 31, 2002
PROFILE 1320 LASER SYSTEM
K022466 · GEX
General & Plastic Surgery · 159d
Cleared Oct 18, 2002
PROFILE 1320 LASER SYSTEM
K022381 · GEX
General & Plastic Surgery · 88d
Cleared Nov 05, 2001
SCITON IMAGE HAIR REMOVAL LASER
K012552 · GEX
General & Plastic Surgery · 89d
Cleared Mar 01, 2001
CONTOUR PROFILE LASER
K010285 · GEX
General & Plastic Surgery · 29d
Cleared Dec 04, 2000
SCITON IMAGE HAIR REMOVAL LASER
K002853 · GEX
General & Plastic Surgery · 82d
Cleared Nov 24, 2000
IMAGE VASCULAR LASER
K003046 · GEX
General & Plastic Surgery · 56d
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