2026-09-23

LED Therapy Device FDA and CE Compliance

The compliance split for LED therapy devices: FDA cosmetic boundary in the US versus CE plus IEC 62471 in the EU, and how to keep claims aligned.

In the US, an LED therapy device is generally treated as a cosmetic / low-risk product, so claims must stay inside that boundary.

For the EU, CE marking plus the IEC 62471 photobiological safety report are the baseline for an LED therapy device.

Keep the claim library per market, because the same red-light panel needs different wording in the US and the EU.

The certificate model must match the shipped SKU, or both FDA and CE reviews can stall on a mismatch.

An OEM that ships LED therapy devices to both regions usually holds the FDA-aligned and CE-aligned copy ready.