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submitting for safety certification with our product that integrates the VL53L0X. our UL project engineer is asking for CDRH letter/report. Which I assume is the report showing compliance to IEC 60825-1:2014

Charlie1
Associate
 
4 REPLIES 4
John E KVAM
ST Employee

​Your project engineer is correct. In the US you need the Accession Letter containing the Accession Number, from the Food and Drug Administration (FDA) stating that the manufacturer has filed all the paper work, and is compliant. This  test report is the CDRH.

For the EU, you need the IEC 60825 documentation.

For the VL53l0X and the VL53L1X the Accession Number assigned is the same. It is # 1620534.

I've enclosed the letter - sorry about the poor quality.

If you want the test data, please contact me directly. That information is a touch sensitive, and I'd like to know to whom I am sending it.

john.kvam@st.com


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John E KVAM
ST Employee

UL is a test lab. And if you pay them they will be glad to test the laser for you. But if you don't change the optics, you may use ST's test report to satisfy the FDA an EU that you have done your duty. (Changing the optics by adding a lens will invalidate the test - Flat glass or plastic is ok.)


If this or any post solves your issue, please mark them as 'Accept as Solution' It really helps. And if you notice anything wrong do not hesitate to 'Report Inappropriate Content'. Someone will review it.
HKarp.1
Associate

Hi John,

I am having the exact same issue. I have been asked by UL to provide an IEC 60825 documentation. regarding the VL53L1X.

Anyhow possible you to provide the report?

John E KVAM
ST Employee

I keep posting this thinking someone could search the site for it.

But the search returned answers and not re-directs to the main submittal.


If this or any post solves your issue, please mark them as 'Accept as Solution' It really helps. And if you notice anything wrong do not hesitate to 'Report Inappropriate Content'. Someone will review it.