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., part of Pfizer. FDA records under its name, each linked to the record. See the Pfizer group view.
As of Nov 13, 2026, FDA's public records list Pfizer Laser Systems with 32 510(k) clearances. The most recent is a 510(k) clearance dated Nov 16, 1993: ORION YAG LASER SYSTEM OPHTHALMOLOGY.
| Nov 16, 1993 | ORION YAG LASER SYSTEM OPHTHALMOLOGYK910826 · GEX | 510(k) clearances |
| Nov 16, 1993 | ORIONK911288 · GEX | 510(k) clearances |
| Feb 26, 1993 | ORION YAG LASER SYSTEM EAR, NOSE, & THROAT APPLIC.K910825 · GEX | 510(k) clearances |
| Jun 16, 1992 | POLARIS, GYNECOLOGY INDICATIONSK912067 · GEX | 510(k) clearances |
| Apr 15, 1992 | ORIONK910152 · GEX | 510(k) clearances |
| Dec 31, 1991 | SIRIUSK912813 · GEX | 510(k) clearances |
| Nov 7, 1991 | POLARIS, OPHTHALMOLOGYK911926 · GEX | 510(k) clearances |
| Oct 16, 1991 | POLARIS, ORAL INDICATIONK912063 · 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
