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Flawless beauty2/21/2023 ![]() ![]() § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. Issuing Office: Center for Devices and Radiological Healthĭuring an inspection of your firm located at 1750 Brielle Ave, Suites A3, A4, and A6, Ocean, NJ, on Novemthrough January 19, 2022, investigators from the United States Food and Drug Administration (FDA) determined that your firm, under 21 CFR 807.3(g), is an initial importer of the Relumins Premium Derma Pen (SKU: RL-DERMAPEN), Relumins Premium Derma Pen Plus (SKU: RL-DERMAPENPLUS), MESOpower pen and needle modules (SKU: MS-POWERPEN), Relumins Branded 35 needle Dermastamper (SKU: RL-STAMPER-35), Relumins Branded 80 needle Dermastamper (SKU: RL-STAMPER-80), Relumins branded 1200 needle Dermaroller 1.0 mm (SKU: RL-DERMROLLER1200-1.00mm, Relumins branded 1200 needle Dermaroller 2.0 mm (SKU: RL-DERMROLLER1200-2.00mm), and Relumins Intense Glow Beauty Care Tool (SKU: RL-BEAUTYTOOL). ![]()
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