Initial dialogue with FDA, they consider it as a home use, non-diagnostic breast transilluminators product whose purpose is as an aid to breast self-examination. It’s a Class 1 medical device in the United States. The Breastlight is designed as a low power with internal battery device.
Breastlight is designed to be eye safe at maximum power setting. This has been designed and tested as a Class 1 LED product to IEC/EN60825-1(2001).
The Fine Print
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