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 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Hamilton Thorne, Inc. with 6 510(k) clearances. The most recent is a 510(k) clearance dated Jul 2, 2021: LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS).
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.
| Jul 2, 2021 | LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)K202241 · MRX | 510(k) clearances |
| Nov 19, 2020 | GM501 Wash with Phenol Red and GentamicinK192503 · MQL | 510(k) clearances |
| Apr 23, 2020 | GM501 SpermAir and GM501 SpermActiveK192644 · MQL | 510(k) clearances |
| Sep 18, 2019 | GM501 Mineral OilK191552 · MQL | 510(k) clearances |
| Sep 5, 2019 | GM501 WashK190383 · MQL | 510(k) clearances |
| Apr 24, 2012 | HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOSK120055 · MRX | 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