Medical device makerLabelled 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 14, 2026, FDA's public records list Australian Optical Co. with 8 510(k) clearances. The most recent is a 510(k) clearance dated Sep 14, 1994: SUNGLASSES.
| Sep 14, 1994 | SUNGLASSESK943562 · HQY | 510(k) clearances |
| Sep 14, 1994 | SPECTACLE FRAMEK943561 · HQZ | 510(k) clearances |
| Sep 14, 1994 | SUNGLASS CLIPK943640 · HQY | 510(k) clearances |
| Sep 14, 1994 | SPECTACLE FRAMEK943641 · HQZ | 510(k) clearances |
| Feb 16, 1994 | SUNGLASS FRAMEK935678 · HQY | 510(k) clearances |
| Dec 8, 1993 | SPECTACLE FRAMEK930331 · HQZ | 510(k) clearances |
| May 6, 1991 | SPECTACLE FRAMEK911332 · HQZ | 510(k) clearances |
| Apr 10, 1991 | OPTICAL FRAMEK910179 · HQZ | 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
