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 15, 2026, FDA's public records list Premier Laser Systems with 14 510(k) clearances. The most recent is a 510(k) clearance dated Nov 18, 1999: AURORA SL.
| Nov 18, 1999 | AURORA SLK993285 · GEX | 510(k) clearances |
| Sep 22, 1999 | AURORA HLK992374 · GEX | 510(k) clearances |
| Aug 20, 1999 | BLULAZEK992620 · GEX | 510(k) clearances |
| Nov 23, 1998 | AURORAK981379 · GEX | 510(k) clearances |
| Oct 9, 1998 | CENTAURIK983211 · GEX | 510(k) clearances |
| Aug 24, 1998 | PEGASUS ND:YAG LASER SYSTEMK980559 · GEX | 510(k) clearances |
| Jul 15, 1998 | AURORA DIODE LASER SYSTEMK974586 · GEX | 510(k) clearances |
| Mar 19, 1998 | DERMIUMK980561 · 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
