This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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 | K211979 | Lumenis Y&R Laser System | 2022-06-21 |
| US | K212703 | AcuPulse CO2 Laser System, Delivery Devices and Accessories | 2021-10-19 |
| US | DEN200028 | Lumenis Stellar M22 | 2021-02-23 |
| BR | 80047309037 | FIBRA ÓPTICA DUOTOME SIDELITE | Class II |
| BR | 80047300318 | SLIMLINE FIBRA DESCARTÁVEL EZ | Class I |
| BR | 80047300330 | SLIMLINE FIBRA REUTILIZÁVEL BLUE JACKET | Class I |
| CA | 9884 | ULTRAFINE ERBIUM LASER AND ACCESSORIES | Class II |
| CA | 64595 | NOVUS TTX OPHTHALMIC LASER | Class III |
| CA | 61181 | RELUME REPIGMENTATION PHOTOTHERAPY SYSTEM | Class II |