Medical device recalls Moderate risk

Aerolase Corporation recalls LightPod Neo Lasers

Recall date
August 1, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0769-2020
FDA classification
Class II
Brand / firm
Aerolase Corporation
Sold / distributed
US Nationwide Distribution

Why it was recalled

This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

LightPod Neo Lasers

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