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Talk to a SpecialistTalk to a SpecialistFlawless Beauty and Skin was cited for importing eight dermatological devices—including microneedling pens, dermastampers, and dermarollers under the Relumins brand—without required premarket approval or an approved Investigational Device Exemption (IDE). The devices were determined to be adulterated under federal law because they lacked the necessary regulatory clearance or approval required for medical devices intended to treat skin conditions and affect body structure or function. The FDA conducted an inspection of the company's Ocean, New Jersey facility between November 2021 and January 2022, during which investigators reviewed product packaging, labeling, user manuals, and website marketing materials to establish the violation.