Medical device recalls Moderate risk

GAGA PRO LIGHTING EQUIPMENT CO., recalls GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonst…

Recall date
September 23, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1290-2023
FDA classification
Class II
Brand / firm
GAGA PRO LIGHTING EQUIPMENT CO.,
Sold / distributed
US Nationwide Distribution

Why it was recalled

GAGA Pro LLS systems was not in compliance with the FDA's Performance Standard for laser products.

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

What was recalled

GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.

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