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 | K223838 | Catalys Precision Laser System | 2023-04-12 |
| US | K220516 | CATALYS Precision Laser system | 2022-05-17 |
| US | K210701 | CATALYS Precision Laser System | 2021-04-07 |
| BR | 80147060141 | iDesign Refractive Studio | Class II |
| BR | 80147060118 | INTERFACE DO PACIENTE INTRALASE | Class II |
| BR | 80147060148 | Interface Liquid Optics | Class II |
| CA | 69764 | INTRALASE FS30 LASER | Class III |
| CA | 73604 | INTRALASE FUSION LASER | Class III |