SkinPen review: Deceptive advertizing

This article shows how the SkinPen is sold under false pretenses. It is deceptively advertised and outrageously overpriced. It was unlawfully sold in the US and the FDA sent its US importer a Cease & Desist letter in 2016.

The SkinPen is a Chinese-made, repurposed permanent makeup machine (rebranded and given dermaneedling cartridges). Bellus Medical, a division of Crown Aesthetics, imports to, and markets this cheaply-made Chinese device in the US. Its source is a Chinese manufacturer or wholesaler. Similar devices are cheaply available on AliBaba:

The SkinPen costs $4,995 and the cartridges are $30 a piece ($360 for a set of twelve). These outrageous prices are necessary to provide a salary for Bellus' large salesforce and top-heavy executive team. Due to their FDA-approval to get their device listed as a Class II device, they can only legally sell to medical professionals so they must charge twenty times more than other devices and cartridges sell for, since there are at least twenty times less practitioners than DIY users.

One would expect extraordinary quality, safety and efficacy from such an over-priced device and Bellus does their best to scam potential buyers into thinking it's a quality American product: They falsely claim the Skinpen is engineered, designed and made in the USA. If Crown/Bellus has evidence to the contrary and deems this a libelous statement, we're happy to see them in court.

LinkedIn's Crown Esthetics employee page lists 58 people, some working for Crown Esthetics, some for Bellus Medical. All are in sales. Zero in medical instrument design, testing, R&D, materials purchasing or manufacturing. No designer/engineer/manufacturer of medical devices employs only salespeople. These companies are trading, not manufacturing. We are a manufacturer of a dermaneedling device that we invented and most of our employees are in engineering, programming, manufacturing, testing and component purchasing. Running a factory and R&D lab and doing ongoing product improvement is very different from running a slick sales operation. Crown/Bellus' executive management is 100% salespeople. A US manufacturer of such devices would need to import a wide variety of Chinese-made components but Bellus only imported plastic bottles in the past two years at the moment of writing (Dec. 2020).

Joe Proctor, the founder of these companies, has been a salesman all his life according to his LinkedIn page and has no experience in R&D and manufacturing. He has a BBA in Marketing.

He claims to have received an award for inventing the SkinPen. In fact his company received seven "awards" in one go. These bogus "awards" were sold to Bellus by Vanessa Florez, CEO & Founder of Aesthetic Everything. According to the LinkedIn pages, Aesthetic Everything is an influencers network that accepts money in return for a variety of marketing efforts, including issuing fake "awards"for credibility-building purposes. Joe Proctor did not invent the SkinPen and never received a legitimate award for inventing the SkinPen.

The SkinPen (FDA primary device ID 10863221000320) was granted a FDA De Novo classification as a Class II medical device and as such as permitted to be marketed as such in the United States. SkinPen calls their device "FDA-cleared" and thus gives the impression that their FDA registration confers the safety of a well-tested, safe device but nothing could be further from the truth. The FDA does not do any testing but relies on self-certification. All Bellus Medical had to do was show citations in the medical literature that dermaneedling to a depth of 2.5 mm has been found to be generally safe, and that Bellus promises that their device is safe also. That's all it took - plus of course the cumbersome, expensive paperwork filed by their FDA attorneys. Bellus, because they were the first to apply for FDA permission to market a dermaneedling device, had to file for a De Novo application but any other substantially similar devices only need to go through a fast-track 510(k) application, which is granted as a shall-issue formality in a mere 90 days. This is because the FDA now recognizes that Dermaneedling is safe and thus classifies ALL similar dermaneedling devices as US-approved class II medical devices. Here is the printed FDA announcement to classify all dermaneedling devices as class II instruments. Not just the SkinPen! And indeed, more dermaneedling machines are in the 90-day fast-track to approval.

Bellus on falsely calls the treatments with the SkinPen "non-invasive" but that's nonsense - the skin is breached, blood flows and the reason the FDA classified it as a class II medical device proves it IS an invasive treatment. On the paid-for "review" (ad) video on their site they falsely claim that "SkinPen is cleared for safety and efficacy". Absolutely not. All the FDA did was issue it a marketing permission based on a literature review of dermaneedling safety, plus Bellus' claim to the FDA that their device is safe.

The SkinPen's hand unit weighs 5 oz or 140 grams and is very unwieldy. The Derminator's tiny hand unit weighs nearly half that, 75 grams (2.65 oz) and is the size of a plum. The SkinPen user manual claims 6300 rpm – 7700 rpm as the "speed" (up to 128 needle punches per second!) but that is mechanically impossible and also would damage the skin, if that were true. They are at best confusing the rotational speed of their electromotor with the reciprocating frequency of the needles, and at worst guilty of deceptive advertising. SkinPen's needle thickness is 0.229 mm (32 BWG), which is 50% thicker than the Derminator (0.15 mm).

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