Medical Device Manufacturer · US , Palo Alto , CA

Sciton, Inc - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 2000

Recent clearances: JOULE 1064nm System and Accessories, mJOULE RF System and Accessories, Joule diVa System

23
Total
23
Cleared
0
Denied

FDA 510(k) Regulatory Record - Sciton, Inc General & Plastic Surgery ✕

23 devices
1-12 of 23
Cleared CT 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
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