SkinPen Microneedling: The FDA-Cleared Difference
Microneedling is one of the most searched skin treatments in Canada, and one of the most inconsistently performed. Walk-in studios, spas, and medical clinics all offer some version of it, ranging from roller devices to professional medical-grade systems. The outcomes, safety profiles, and regulatory standards of these options vary considerably.
SkinPen by Bellus Medical is the first and only microneedling device to receive FDA clearance for the improvement of the appearance of facial acne scars in adults 22 and older. At GhalMédica, SkinPen is the device used for all microneedling protocols. This reflects a commitment to devices with demonstrated clinical evidence and regulatory oversight.
What Microneedling Actually Does
Microneedling creates controlled micro-injuries in the skin using a matrix of fine needles. These micro-channels trigger the skin's wound-healing response, stimulating collagen and elastin production as the skin repairs itself. Over a series of sessions, this may support improvements in texture, pore appearance, and the look of scarring. Results vary between individuals.
Why FDA Clearance Matters to You
The FDA clearance for SkinPen is specifically for facial acne scars, a meaningful clinical endpoint that required evidence rather than manufacturer claims. That specificity is what separates medical-grade from aesthetic-grade.
SkinPen with PRF: The Biologics Enhancement
Where clinically appropriate, Dr. Ghalehii offers the option to pair SkinPen with PRF (Platelet-Rich Fibrin) derived from the patient's own blood. PRF may complement the collagen-stimulating effects of microneedling by introducing growth factors into the micro-channels created during treatment. This is an optional enhancement discussed during consultation, never assumed.
The GhalMédica SkinPen Protocol
- Three sessions spaced four weeks apart
- Topical anaesthetic applied 30 minutes before each session
- 30 to 45 minutes per treatment
- 24 to 48 hour recovery typical, significantly less than Morpheus8 or ablative laser
- PRF biologics available as an optional enhancement
Dr. Ghalehii will assess your skin and determine whether SkinPen or Morpheus8 is the better clinical fit for your specific concerns.
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