This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel, Russia — 8 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 | K240070 | Profound Matrix | 2024-07-01 |
| US | K230990 | Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) | 2023-06-01 |
| US | K220853 | PicoWay Laser System | 2022-10-13 |
| BR | 81504799191 | Dispositivo de remoção e rejuvenescimento da pele | Class II |
| CA | 29731 | CANDELA MID IR DIODE LASER SYSTEM, WITH DCD (SMOOTHBEAM) | Class III |
| CA | 29825 | CANDELA PULSE DYE LASER, SCLEROPLUSHP | Class III |
| CA | 29943 | CANDELA PULSE DYE DERMATOLOGIC LASER, SCLEROPLUS | Class III |