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 13, 2026, FDA's public records list Directed Energy with 39 510(k) clearances. The most recent is a 510(k) clearance dated Mar 21, 1991: SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CH.
| Mar 21, 1991 | SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CHK904930 · GEX | 510(k) clearances |
| Jun 18, 1990 | MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENTK894241 · GEX | 510(k) clearances |
| Nov 15, 1988 | CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH.K883738 · GEX | 510(k) clearances |
| Sep 9, 1988 | MODEL AU-1 ACCESSORY UNITK882926 · GEX | 510(k) clearances |
| Mar 4, 1988 | MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP.K880216 · GEX | 510(k) clearances |
| Feb 17, 1988 | ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURGK873331 · HRX | 510(k) clearances |
| Feb 2, 1988 | MODEL 20-C, RL-20A/U, OB-10A/UK872709 · HHR | 510(k) clearances |
| Feb 2, 1988 | MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYNK870841 · HHR | 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
