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GlobeNewswire·

SkinStylus® Receives New FDA Clearance for the Improvement of Periorbital Wrinkles for All Skin Types

  • The FDA cleared the SkinStylus SteriLock MicroSystem for improving periorbital wrinkles in adults aged 22+ across all Fitzpatrick skin types I-VI.
  • SkinStylus is now the only microneedling device with FDA-cleared indications for facial acne scars, periorbital wrinkles, & abdominal scars.
  • Existing indications include improving facial acne scars in Fitzpatrick types I-III & surgical/traumatic hypertrophic scars on the abdomen.
  • Microneedling consumer spend in U.S. medical aesthetics grew 33% year-over-year in 2025 to reach approximately $330 million.
  • Approximately one in five Hydrafacial consumers received a microneedling treatment last year, with 90% interested in combining the procedures in the future.
  • Clinical data supporting the new wrinkle indication was presented at the 2026 SCALE Annual Meeting.
  • Dr. Glynis Ablon reported the device showed statistically meaningful improvements in wrinkles & was more comfortable & easier to handle than other systems.
  • SkinStylus is a Class II Medical Device available at providers across the United States.