This company has registrations in United States, Canada — 2 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 | K233157 | VaporMAX LDD; MOJo LDD; MegaJOULE LDD | 2024-05-03 |
| US | K203799 | ProFlex CO2 Laser Fiber | 2021-09-20 |
| US | K180140 | ProFlex Laser Fibers | 2018-04-20 |
| CA | 29604 | SURGICAL FIBERS | Class II |
| CA | 97451 | PROFLEX LASER LITHOTRIPSY FIBER | Class II |