This company has registrations in European Union, United States, Brazil — 3 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 |
|---|---|---|---|
| EU | 06976712970051 | SurgiLight 1470 Diode Laser System | Class IIb |
| EU | 06976712970044 | Halo Sterile Single-use Radial Fiber | Class IIa |
| EU | 06976712970037 | Halo Sterile Single-use Radial Fiber | Class IIa |
| US | K261701 | Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) | 2026-06-18 |
| US | K252745 | Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8) | 2025-12-12 |
| US | K251049 | SurgiLight 1470 Diode Laser System (Model:Halo) | 2025-07-02 |