Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Sciton with 23 510(k) clearances. The most recent is a 510(k) clearance dated Dec 19, 2025: JOULE 1064nm System and Accessories.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Dec 19, 2025 | JOULE 1064nm System and AccessoriesK251077 · GEX | 510(k) clearances |
| Apr 23, 2024 | mJOULE RF System and AccessoriesK222958 · GEI | 510(k) clearances |
| Jul 19, 2022 | Joule diVa SystemK213761 · GEX | 510(k) clearances |
| Apr 15, 2022 | mJOULE System and AccessoriesK213350 · GEX | 510(k) clearances |
| Mar 6, 2019 | Joule SystemK182173 · GEX | 510(k) clearances |
| May 18, 2018 | JOULE SYSTEMK180508 · GEX | 510(k) clearances |
| Jan 29, 2018 | JOULE SYSTEMK173285 · GEX | 510(k) clearances |
| Jun 19, 2013 | JOULE 810/940/980 MULTI-PLATFORM SYSTEMK122567 · GEX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
