08 Apr, 2021, 08:06 ET
DALLAS, April 8, 2021 /PRNewswire/ -- Crown Aesthetics, a division of Crown Laboratories, Inc. and the US leader in Microneedling Technology, announced today that the U.S. Food and Drug Administration (FDA) has cleared SkinPen® Precision for the treatment of wrinkles on the neck.
The administration's decision came following a recent single-center clinical study, which demonstrated clinical improvement of dermal lines on the neck and high patient satisfaction at 1-month and 3-months post treatment1. From this study it was found that:
- 94% of patients noticed an improvement in how their wrinkles looked in their treated area one month post procedure
- 88% of patients were satisfied with their SkinPen Precision treatment one-month post procedure
The clinical trial also showed that the SkinPen Precision device is safe for use with a depth of up to 2.5 mm on the neck. This allows patients to achieve more meaningful results with no adverse effects1. SkinPen is the first and only FDA cleared microneedling device with indications for both Face and Neck.
"This new and expanded indication will completely change the way the industry has been treating wrinkles on the neck," says Joe Proctor, President of Crown Aesthetics. "With SkinPen's microneedling technology, we continue to set a higher standard in patient care as the world's first FDA-cleared microneedling device. SkinPen has been clinically proven to safely and effectively treat facial acne scars in patients ages 22 and up and we are excited to now add the expanded indication to treat wrinkles on the neck. We, at Crown, are fully committed to our practice partners across the globe and their desire to provide superior clinical outcomes to their patients. Through our continuous innovation and constant pursuit of clinical excellence, we continue to drive value and further meet the needs and expectations of our physician partners and their patients."
Crown Aesthetics has already begun the process of publishing the data for the study on this indication and plans to present at global aesthetic dermatology meetings later in the year.
Crown, a privately held, fully integrated global skin care company is committed to developing and providing a diverse portfolio of aesthetic, beauty, and therapeutic skin care products that improve the quality of life for its customers. An innovative company focused on skin science for life, Crown's unyielding pursuit of delivering therapeutic excellence and enhanced patient outcomes is why it has become a leader in Dermatology and Aesthetics. Crown has been listed on the Inc. 5000 Fastest Growing Privately Held Companies List for seven years and has expanded its distribution to over 38 countries. For more information about Crown or its products, visit www.crownlaboratories.com.
About Crown Aesthetics
Crown Aesthetics, the premier medical aesthetics company, is dedicated to helping leading aesthetic practices around the world grow their businesses. We do that by delivering dramatic results in rejuvenation and restoration. Our non-invasive innovations – SkinPen®, the first FDA-cleared microneedling device; the post-microneedling protocol Skinfuse®; and the platelet-rich plasma (PRP) system ProGenTM Advantage – act as "gateway" products that draw new consumers to practices. Based in Dallas, Texas, Crown Aesthetics sets industry standards for efficacy, safety, and innovation. As a result, our customers consistently deliver the best aesthetic care in the business. For more information, please visit www.crownaesthetics.com.
1 510(k) Trade/Device Name: SkinPen Precision System K202243
Indications/Intended use: The SkinPen® Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older.
SOURCE Bellus Medical, a division of Crown Laboratories
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