Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list C.I.S with 1 510(k) clearance and 1 drug application. The most recent is a 510(k) clearance dated Feb 25, 2016: SKIN CARE.
| Date | Record | Source |
|---|---|---|
| Feb 25, 2016 | SKIN CAREK152736 ยท 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
