US FDA
US FDA

US FDA

Item specifics

Expiration Date
2024/12/1 - 2027/12/1
Certification bodies
CDRH

Certificate description

This FDA certificate for laser lights is officially issued by CDRH (Center for Devices and Radiological Health), a subordinate regulatory division of the U.S. Food and Drug Administration. All evaluation and certification work is performed strictly in compliance with 21 CFR 1040.10 and 21 CFR 1040.11, the core federal regulations governing laser‑product radiation safety in the United States.
This certification assesses key safety‑related performances of laser lights, including laser radiation output, protective housing requirements, warning labeling, and interlock‑mechanism performance. It confirms that the product meets U.S. statutory laser‑safety specifications.
As an official document recognized by overseas regulatory authorities, this certificate is essential for U.S. market access. It can be applied for customs clearance, cross‑border platform filing, supplier qualification review, and official regulatory inspections, proving the product’s legal eligibility for import and commercial sale in the United States.