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Professional Microneedling Device Gets Award While OTC Dermal ‘Pen’ Firms Get Warnings

Executive Summary

Flawless Beauty & Skin and Med Pen Concepts sell microneedling systems and/or other tools with claims about treating hyperpigmentation, acne scars, fine lines and wrinkles, making the products noncompliant medical devices under FDA regulations, agency says. Crown Aesthetics's SkinPen Precision meanwhile named “Best in Industry-Nonsurgical Innovation” by The Aesthetic Guide.

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