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Marci Beauty LLC was warned for marketing seven light therapy devices (Jupiter, Vega, Neptune, Luna, Cosmo, Nova, and Galaxa) without required FDA marketing clearance or approval. The company violated federal law by failing to obtain premarket approval (PMA) or investigational device exemption (IDE) before commercial distribution, and did not submit the required section 510(k) notification. The devices were deemed adulterated and misbranded based on the company's own website claims indicating the products were intended to treat medical conditions including wrinkles, acne, and skin damage.