This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 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.
Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K220032 | iStent infinite Trabecular Micro-Bypass System, Model iS3 | 2022-08-02 |
| US | K212797 | iPrime Viscodelivery System | 2022-01-06 |
| BR | 81456179001 | iprism® SX | Class II |
| BR | 80117580535 | Iprism CLIP | Class II |
| BR | 81456170001 | iprismS | Class II |
| CA | 80717 | ISTENT TRABECULAR MICRO-BYPASS INSERTER | Class II |