First Microneedling Pen Approved by the FDA

  • March 16, 2018

The SkinPen® Has Been Approved by the FDA for MicroNeedling

Microneedling, also known as collagen induction therapy, is a skin rejuvenation procedure that helps the signs of aging, improves appearance of scars, and rejuvenates aging skin.

In a Press Release released by Bellus Medical, the makers of SkinPen®, it was announced the FDA has cleared the SkinPen® Precision Microneedling Device as the ONLY Safe and Legally Marketed Microneedling System in the U.S.

This sets a new standard as the only recognized Class II Microneedling device available. Caddell’s Laser Clinic has been performing Microneedling using the SkinPen® for several years with fantastic results.


Consumers are experiencing highly effective and meaningful benefits offered by the SkinPen®, including:

  • Little to no downtime
  • Effective for all skin types, light to dark
  • Comfortable experience
  • Short procedure time
  • Ideal any time of the year
  • Real results from a safe, natural and minimally invasive procedure
  • Clinically-proven, safe and effective

What is Microneedling? And What Are The Benefits?

During a SkinPen® Microneedling treatment, a device with tiny acupuncture needles causes controlled micro-injuries that cause the skin to trigger your immune system to disinfect the wounds, remove debris, increase blood flow and start to create new tissue. The treatment usually takes about 30 minutes to an hour. There is usually some slight redness/pinkness, like a mild sunburn, for two to four days although some people see their skin return to normal in less than 24 hours.

After the treatment, and as the wound heals, a temporary type of collagen re-builds the area along with a new network of blood vessels developing in the treated area. Microneedling can be used on many body parts. The SkinPen® needle depth adjusts from .25 mm to 2 mm allowing for tailored treatments. And because there’s no damage to the epidermis it doesn’t trigger inflammation, meaning infections and scarring are unlikely. After treatment, it is important to use a high-quality skin care regimen which will also assist in recovery.


The third part of the Microneedling healing process is when the wound is replaced with new dermal tissues and blood vessels. The collagen in the newly formed tissue is replaced with stronger collagen which can contract to create a tightening effect on the skin. During this time, the patient will see an improvement in the appearance of acne scars and the rejuvenation of aging skin. One study of 60 patients with acne scarring, report they saw a 31% improvement in skin texture after three Microneedling treatments with the SkinPen®.

What’s Different About the SkinPen?

The SkinPen® Precision is the only Class II, FDA cleared Microneedling Device. It includes sterile cartridges that deliver exact depth and have straight needles that support the skin’s natural healing process, unlike other devices that may damage the skin. Bellus Medical, the makers of the SkinPen®, raises the bar with superior technology that delivers exceptional reliability, safety and performance.

If you want noticeably healthier skin, using a safe and effective treatment then you owe it to yourself to try Microneedling with the SkinPen®. Call Caddell’s today to book your Microneedling appointment.


Microneedling treatments using the SkinPen® as seen on:


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