XCELLARISPRO TWIST microneedling device

The XCELLARISPRO TWIST is a powered microneedling device that creates microscopic punctures in facial skin using six stainless-steel needles. It is intended to improve the appearance of facial acne scars in Fitzpatrick skin types I-IV and treat wrinkles (glabellar frown lines, periorbital lines, and cheek folds) in Fitzpatrick skin types I-III in adults aged 22 or older.

The device operates at a frequency range of 50-150 Hz (recommended 100-150 Hz) with adjustable needle protrusion depth from 0-2.5 mm (recommended maximum 1.5 mm). It contains six stainless-steel needles in squared arrangement, each 2.5 mm long, mounted in a single-use sterile needling module. Key differences from predicates include a broader frequency range than the Exceed device, though with similar recommended working frequencies and identical maximum needle penetration depth of 1.5 mm.

Testing performed per ISO 11737-2 and ISO 11135 (sterility), ISO 11607-1 (shelf life and package integrity), IEC 60601-1 and IEC 60601-1-2 (electrical safety and EMC), and ISO 10993-1 (biocompatibility including cytotoxicity, irritation, sensitization, and acute systemic toxicity). Non-clinical performance testing included high-speed camera measurement of needle protrusion accuracy and puncture rate in pig skin.

The device shares identical product code (QAI), device classification, intended use (facial aesthetic treatment), prescription-use status, location of use (face), sterilization method (ethylene oxide), and recommended needle penetration depth (1.5 mm) with predicate devices. Although frequency range and specific design differ, non-clinical performance testing demonstrates the device performs as intended and poses no undue or additional risks. General controls and special controls (including non-clinical performance testing) establish that technical differences do not raise new safety or effectiveness questions compared to predicates.