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US FDA

Aug 5,2026
US FDA
  • Expiration Date:
  • Dec 1,2024 - Dec 1,2027
  • Certification bodies:
  • CDRH
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.
Define Tone in Dark
Contact Person
Lumi Deng
Full Name:
Lumi Deng
Tel:

+86 13414288613

Email:
sales1@darktone.com
WhatsApp:
8613414288613
Address:
Room B441, 7/F, No.13-33 Jinshi 3rd Road, Dayuan Sub-district, Baiyun District, Guangzhou City, Guangdong Province, P.R.China