This company has registrations in United States, Canada, Taiwan, Singapore, Australia — 5 overseas markets. The China NMPA lookup is still pending.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K233811 | DT Controlled Phototherapy Equipment | 2023-12-13 |
| US | K230382 | 3 Series NeoLux | 2023-03-24 |
| US | K220840 | 1 Series Phototherapy Equipment | 2022-04-22 |
| CA | 73529 | 3 SERIES FLUORESCENT ULTRAVIOLET LIGHT CABINET | Class II |
| CA | 77106 | LUMERA TARGETED PHOTOTHERAPY SYSTEM | Class II |
| CA | 80241 | M SERIES HAND OR FOOT PHOTOTHERAPY UNIT | Class II |