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The FDA Approves Microneedling Pen

The FDA Approves Microneedling Pen

Microneedling, also known as collagen induction therapy, is a minimally invasive skin rejuvenation procedure that helps minimize the signs of aging, improve the appearance of acne scars and rejuvenate aging skin. The SkinPen Precision system is the only Class II, FDA cleared microneedling device legally marketing in the U.S.; it is the first microneedling company with ISO 13485:2016 certification.

The SkinPen microneedling device causes controlled micro-injuries that stimulate the body’s natural wound healing process. The micro-injuries trigger the release of cytokines and growth factors that lead to remodeling of collagen and elastin.

SkinPen creates hundreds of tiny micro-channels in the skin with minimal damage to the epidermis. SkinPen disrupts the junctions between the skin cells, temporarily disrupting the skin’s barrier function. This brief, mechanical disruption does not cause the melanocytes (pigment-producing cells) in the epidermis to react by increasing pigment production and darkening the skin in a process called hyperpigmentation.

Microneedling has been shown to help improve the appearance of acne scars. In one study of 60 patients with acne scarring, three micro-needling treatments resulted in a 31 percent improvement in skin texture, with no discoloration of the skin. Micro-needling was effective for all skin types.


It’s safe. SkinPen has several safety features:

• An exhaust port prevents suction and reduces the risk of broken capillaries.

• Sterile, disposable needle cartridges reduce the risk of infection.

• Bio Sleeve technology eliminates cross-contamination by preventing fluids from leaking beyond the micro-needle cartridge.

There are minimal side effects and downtime. Patients may experience some slight swelling, tenderness and redness/pinkness (like a mild sunburn) lasting a few days after their procedure. Most people can return to their normal activities and conceal any side effects with makeup just one day after their SkinPen procedure.

There’s minimal risk of scarring and infections. Because SkinPen doesn’t remove or damage the epidermis and doesn’t trigger the inflammatory pathway, infections and scarring are unlikely.

It works on all skin types and colors. Because SkinPen doesn’t cause bleaching or hyperpigmentation, it can be used on all skin types, including darker skin that is more susceptible to hyperpigmentation.

It can be used on most body parts. Variable needle depths allow SkinPen to be safely used on most body parts.