Quality Certifications & Compliance
Our diode laser hair removal machines meet the most stringent international quality and safety standards. All machines ship with full certification documentation for your local regulatory requirements.
[CE Certificate]
European Medical Device Directive
[FDA 510(k)]
US Food and Drug Administration
[ISO 13485]
Medical Device Quality Management
Our Certifications
- CE Marking (Medical Device Directive 93/42/EEC): Required for European Union and many other markets
- FDA 510(k) Clearance: For legal sale and use in the United States
- ISO 13485:2016: Medical device quality management system certification
- IEC 60601-1: Medical electrical equipment safety standard
- EN 60825-1: Laser product safety classification
Import Support
We provide complete documentation packages for customs clearance including Certificate of Origin, Commercial Invoice, Packing List, and product certifications specific to your destination country.