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.
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 | K230228 | Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) | 2023-02-23 |
| US | K223132 | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) | 2022-11-09 |
| US | K213592 | Iridex 810 Laser | 2022-03-23 |
| BR | 81770689003 | Sondas Iridex | Class II |
| CA | 38685 | IRIDEX DIOLITE LASER SYSTEM | Class III |
| CA | 39263 | IRIDEX APEX 800 DIODE LASER SYSTEM | Class III |
| CA | 69146 | IRIDEX SCANLITE SCANNER | Class II |