# Sciton, Inc

- Location (FDA's records): Palo Alto, CA
- FDA decisions: 23 (2000–2025): 23 510(k) clearances
- Product codes: GEX (21), PDZ (1), GEI (1)
- 510(k) review time since 2016: median 208 days, against 90 for FDA's reviews in the same codes and years (0 of 7 faster)
- Predicates its devices cite: 117 (23 its own); citations of its devices by later devices: 67 (23 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Candela Corp.: 11 (https://510kreport.com/company/candela)
- New Star Lasers, Inc.: 9 (https://510kreport.com/company/new-star-lasers)
- Palomar Medical Technologies, Inc.: 7 (https://510kreport.com/company/palomar-medical-technologies)
- Laserscope: 7 (https://510kreport.com/company/laserscope)
- Cynosure, Inc.: 6 (https://510kreport.com/company/cynosure)
- Altus Medical, Inc.: 6 (https://510kreport.com/company/altus-medical)
- Cooltouch Corp.: 4 (https://510kreport.com/company/cooltouch)
- Lumenis, Inc.: 4 (https://510kreport.com/company/lumenis)

## Firms that cite its devices most
- Cutera, Inc.: 3 (https://510kreport.com/company/cutera)
- Global USA Distribution, LLC: 3 (https://510kreport.com/company/global-usa-distribution)
- Msq (M2), Ltd.: 3 (https://510kreport.com/company/msq-m2)
- Litecure, LLC: 2 (https://510kreport.com/company/litecure)
- Alma Lasers, Inc.: 2 (https://510kreport.com/company/alma-lasers)
- Wavelight Laser Technologie AG: 2 (https://510kreport.com/company/wavelight-laser-technologie)
- Palomar Medical Products, Inc.: 2 (https://510kreport.com/company/palomar-medical-products)
- Genesis Biosystems, Inc.: 2 (https://510kreport.com/company/genesis-biosystems)

## Its most-cited devices
- K032460: Profile BBL System (2003), cited by 10
- K060033: Profile Multi-Platform System (2006), cited by 9
- K070388: Profile Multi-Platform System (2007), cited by 8
- K040005: Profile 2000/3000 Laser System (2004), cited by 6
- K101916: Joule Multi-Platform System (2011), cited by 6
- K023881: Profile 1064 Laser System (2003), cited by 5

## Recent decisions
- K251077: JOULE 1064nm System and Accessories (Dec 19, 2025)
- K222958: mJOULE RF System and Accessories (Apr 23, 2024)
- K213761: Joule diVa System (Jul 19, 2022)
- K213350: mJOULE System and Accessories (Apr 15, 2022)
- K182173: Joule System (Mar 6, 2019)
- K180508: Joule System (May 18, 2018)
- K173285: Joule System (Jan 29, 2018)
- K122567: Joule 810/940/980 Multi-Platform System (Jun 19, 2013)

Source page: https://510kreport.com/company/sciton