Legal Certifications & Compliance
We meet the highest global standards in surgical fiber safety and performance.
Medical LAser Fiber Certificates & Registrations
At Surgical Fiber Dynamics, we proudly distribute MED-Fibers products — rigorously tested, fully certified, and legally cleared for use with FDA-approved laser systems (excluding those with RFID connectors).
Our medical laser fiber certification reflects our commitment to quality, safety, and compliance within the medical device industry. Surgical Fiber Dynamics follows strict standards to ensure our laser fibers meet professional and clinical requirements.
Our commitment to quality, safety, and compliance ensures all products meet the strictest international standards for medical device manufacturing and laser fiber safety.
Medical Laser Fibers Certified for Global Use
| Certification | Description |
|---|---|
| FDA 510(k) | Cleared under K124003 for safe and effective use |
| CE Marking | Certified for compliance in the European Union |
| ISO 13485:2016 | Quality management standard for medical device manufacturers |
| NF EN ISO 13485:2016 | French standard equivalent of ISO 13485 compliance |
| Certificate of Conformity | Confirms adherence to all technical and legal safety requirements |
All devices are FDA-cleared, CE-marked, and ISO 13485 certified.
Available Documents for Download
Use the links below to download official certification files in PDF format.
