This company has registrations in United States, Canada — 2 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 | K253400 | LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) | 2025-12-24 |
| US | K153389 | Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) | 2016-03-30 |
| US | K022888 | ACUBEAM, SUPER NOVA, DIO | 2002-12-11 |
| CA | 27308 | LIGHT THERAPY DEVICE | Class II |