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This Microneedling Device Just Got FDA Clearance for Under-Eye Wrinkles

Now cleared for all Fitzpatrick skin types.

A gloved hand holds a SteriLock microneedling device close to a woman's lower face as she tilts her chin upward, mid-treatment.
SkinHealth Systems

If concealer has started settling into fine lines or you've noticed the skin under your eyes looking thinner and crepier, there's new microneedling news worth knowing. The FDA has expanded the indications for the SkinStylus SteriLock MicroSystem, making it the first device with clearance "to improve the appearance of under-eye wrinkles, including crow's feet, in adults 22 and older across all Fitzpatrick skin types."

Microneedling has quickly become one of the most sought-after treatments for improving skin quality, and demand continues to grow. According to Guidepoint Qsight 2025 data, cited by SkinHealth Systems, Americans spent approximately $330 million on microneedling treatments in 2025, a 33 percent increase over the year prior.

While many aesthetic physicians already use microneedling to treat the under-eye area, an FDA-cleared indication means the device has been specifically evaluated for that use. For anyone looking to soften crow's feet or improve crepey, thinning skin under the eyes, it offers another FDA-cleared treatment option to discuss with their provider.

The new clearance also adds to SkinStylus' growing list of FDA-cleared uses. According to the company, it is now the only microneedling device with FDA-cleared indications for facial acne scars, under-eye wrinkles and abdominal hypertrophic scars, making it one of the most broadly indicated devices in the category.

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