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 Niic U.S.A., Inc. with 16 510(k) clearances. The most recent is a 510(k) clearance dated Oct 2, 1990: MODEL IS102S ND:YAG SURGICAL LASER SYSTEM.
| Oct 2, 1990 | MODEL IS102S ND:YAG SURGICAL LASER SYSTEMK902133 · GEX | 510(k) clearances |
| Aug 14, 1990 | MODELS IR103,IR107,IR104,IR205 (ADD'L APPLICATION)K901205 · GEX | 510(k) clearances |
| Jun 29, 1990 | NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEMK902063 · GEX | 510(k) clearances |
| Jun 5, 1990 | EXPANDED MARKETING OF MODELS IR104 & IR205 LASERSK901204 · GEX | 510(k) clearances |
| May 24, 1990 | NIIC MODEL: DX901 ASPIRATION SYSTEMK900185 · JFL | 510(k) clearances |
| Jan 23, 1990 | NIIC LASER SYSTEMK896988 · GEX | 510(k) clearances |
| Dec 13, 1989 | MODEL: IR205 ARTICULATED SURGICAL LASERK895581 · GEX | 510(k) clearances |
| Nov 16, 1989 | MODEL NUMBER: IR204 CO2 SURGICAL LASER SYSTEMK892359 · 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
