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 | K252732 | 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) | 2025-10-23 |
| US | K251339 | Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) | 2025-07-25 |
| US | K250782 | Fractional CO2 Laser Machine | 2025-06-12 |
| BR | 80451969021 | Rennova Elleva Pro | Class II |
| BR | 80451969022 | Rennova Complete | Class II |
| BR | 80451969023 | Rennova Silluet | Class II |