SkinPen should not be used on patients who have active skin cancer in the treatment area(s); open wounds, sores, or irritated skin in the treatment area(s); an allergy to stainless steel or anesthetics; a hemorrhagic (bleeding) disorder or hemostatic (bleeding) dysfunction; are pregnant or nursing; or are currently taking drugs with the ingredient isotretinoin (such as Accutane).
Much confusion exists over who can perform microneedling; however, AmSpa believes that most states consider or will consider microneedling to be a medical treatment. Most state boards have indicated that, because it involves the use of needles, it is a medical treatment that should only be performed by medical professionals under the supervision of a physician. AmSpa is aware that it is common that estheticians perform this procedure; however, most state boards do not approve of this practice. Because of this, and because it is considered a medical treatment, prior to your initial treatment, the medical spa should conduct an in-person exam by either a doctor, a nurse practitioner or a physician assistant. Please check with your local medical board, nursing board or health care attorney for more information.
For patient safety and protection, SkinPen is available only through a physician.
SkinPen’s patent-pending and single-use sterile needle cartridge is built with safety in mind. SkinPen is also surrounded by a proprietary BioSheath that acts as a barrier to prevent cross contamination between procedures.1 No other manufacturer can make that claim, which is part of the reason SkinPen by Bellus Medical is the only FDA-cleared microneedling device. Learn more by reviewing our patient labeling document.
The U.S. Food and Drug Administration’s clearance covers not only the SkinPen device but the entire protocol. That includes the Skinfuse® Lift HG hydrogel used to protect against abrasion and friction during the treatment, as well as the custom-designed BioSheath to prevent cross contamination.1
Data on file. Bellus Medical. 2017.  Data on file. Bellus Medical. 2016.
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