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 14, 2026, FDA's public records list Theradome, Inc. with 5 510(k) clearances. The most recent is a 510(k) clearance dated May 18, 2018: Theradome LH40.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 18, 2018 | Theradome LH40K180460 · OAP | 510(k) clearances |
| Jan 9, 2018 | Theradome LH80 PROK171775 · OAP | 510(k) clearances |
| May 12, 2016 | Laser Helmet LH40-EVOK161046 · OAP | 510(k) clearances |
| Jun 14, 2013 | LASER HELMETK122950 · OAP | 510(k) clearances |
| Mar 2, 2012 | LASER HELMETK113097 · OAP | 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
