SkinStylus SteriLock MicroSystem (MP1209SL)

The SkinStylus SteriLock® MicroSystem is a handheld microneedling device that uses a powered motor to rapidly reciprocate an array of 36 microneedles (2.5 mm maximum length) to create microinjuries in the skin. It is intended to treat periorbital wrinkles in Fitzpatrick skin types I–VI in adults aged 34 years or older, and is also cleared for abdominal scarring and facial acne scars.

The subject device uses 36 needles arranged in a 6×6 square (versus 6 needles in the predicate), operates at 6200–8840 RPM (similar to predicate's 6000–9000 RPM), has a maximum penetration depth of 2.5 mm (versus 1.5 mm in predicate), and uses 5V DC power (versus 15V DC in predicate). Both use sterile single-use disposable cartridges with stainless steel needles and identical treatment protocols.

Biocompatibility testing per ISO 10993-5, 10993-10, and 10993-11; sterility validation per ISO 11737-1 and 11737-2; electrical safety per IEC 60601-1 and 60601-1-2; battery safety per IEC 62133-2 and UN38.3; packaging integrity per ASTM F88, F1929, and F1608.

Both devices are prescription-only powered microneedling systems using multiple needles to mechanically puncture skin for aesthetic use. Clinical testing demonstrated the subject device achieves the primary endpoint of ≥1 grade improvement in periorbital wrinkles on the Lemperle scale at days 120 and 150, with 80% of subjects showing improvement per blinded physician review. Although the subject device differs in needle geometry, penetration depth, and power specifications, clinical and non-clinical performance testing demonstrate safety and effectiveness equivalent to the predicate (Exceed, K180778) and raise no new questions regarding safety.