Candela Laser (Deutschland) GmbH
Medical Aesthetic Laser Equipment | Candela
Since 1970, Candela Medical has been a US-based manufacturer of FDA-cleared laser, IPL, RF microneedling, and hydro-infusion microdermabrasion devices trusted by medical professionals across 89 countries
- Type
- Manufacturer
- Location
- Neu-Isenburg, Germany
- Founded
- 1970
- Website
- https://candelamedical.com
- Categories
- Medical & Healthcare Supplies
Verified facts
- domain-registered (green), checked 2026-08-02 Domain registry record
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- debarment-clear (green), checked 2026-08-16 OpenSanctions
- sanctions-clear (green), checked 2026-08-16 OpenSanctions
- registry-active-global (green), checked 2026-07-08 Handelsregister (North Data)
Profiles
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)