Data / Medical devices / United States / Sciton, Inc.
Sciton, Inc.: FDA-registered device maker in Palo Alto, CA, United States, 4 510(k) clearances
Sciton, Inc. is registered with the FDA (registration 2953696) in Palo Alto, CA, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 19, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2953696
- FEI number
- 3001415984
- Address
- 925 Commercial Street, Palo Alto, CA, United States, 94303
- Owner or operator
- SCITON, INC. (9033367)
- Roles
- Complaint file establishment, Manufacturer, Remanufacturer
- First device listed
- February 1, 2008
- Registered through
- 2026
- Brand names listed
- BBLs, JOULE Multi-Platform System, JOULE diVa Laser Device, Joule, Profile, mJoule
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser Assisted Lipolysis | ORK | 2 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | 2 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 19, 2022 | K213761 | Joule diVa System | GEX | Substantially Equivalent | Sciton, Inc | accessdata.fda.gov |
| March 6, 2019 | K182173 | Joule System | GEX | Substantially Equivalent | Sciton, Inc | accessdata.fda.gov |
| March 18, 2011 | K101916 | JOULE MULTI-PLATFORM SYSTEM | GEX | Substantially Equivalent | Sciton, Inc | accessdata.fda.gov |
| May 2, 2007 | K070388 | PROFILE MULTI-PLATFORM SYSTEM | GEX | Substantially Equivalent | Sciton, Inc | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Laser Assisted Lipolysis
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- All makers of Powered Laser Surgical Instrument With MicrobeamFractional Output
- All makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Updated July 19, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.