www.fdanews.com/articles/202273-crown-aesthetics-microneedle-cleared-for-neck-wrinkles
Crown Aesthetics’ Microneedle Cleared for Neck Wrinkles
April 12, 2021
Crown Aesthetics has received additional 510(k) clearance from the FDA for its SkinPen Precision microneedle, allowing the use of its device for treating wrinkles on the neck.
The device was previously cleared by the FDA for treating facial acne scars. With its additional clearance, it is now the only microneedle device with indications for both the face and neck, the company said.
The microneedle works by creating controlled micro-injuries that spur the body’s natural wound-healing process while minimizing cellular damage, effectively remodeling scar tissue while preserving skin structure.