This company has registrations in United States, Brazil, Canada, Australia, Israel — 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 | K241670 | Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) | 2024-12-20 |
| US | K233307 | Intensity Pulsed Light Therapy System | 2024-03-15 |
| US | K231896 | Diode Laser Therapy System | 2024-02-20 |
| BR | 80451960251 | Rennova Arctic | Class I |
| BR | 80451969017 | Rennova da Vinci | Class II |
| BR | 80451969016 | Ultrassom Focalizado de Alta Intensidade | Class II |