The CPAP Mask Microbial Reduction Device recently earned clearance from the US Food & Drug Administration

SARASOTA, Florida—LiViliti Health Products Corp. has announced the market introduction of the Paptizer 360, its next-generation CPAP Mask Microbial Reduction Device. The device recently earned 510(k) clearance from the U.S. Food and Drug Administration (FDA) as a Class II medical device, validating its design, safety and performance standards for home use.

The Paptizer 360 is an FDA-cleared UV-C LED microbial reduction device for single-patient home use. It is intended as an adjunct to reduce bacterial populations on certain compatible home-use CPAP mask cushions after cleaning.

Key features include:

  • 30-minute cycle: An LCD counts it down, then the unit shuts itself off. Four buttons: ON, START, PAUSE, OFF.
  • 40 UV-C LEDs: 260 to 280 nm, rated for up to a 10,000-hour lifespan. LEDs, so there's no lamp or filters to change.
  • Lid safety sensor: Open the lid mid-cycle and the LEDs cut out. No UV-C exposure to eyes or skin.
  • Quartz glass tray: A special quartz-glass blend lets UV-C light pass through the tray for full 360-degree microbial reduction around the cushion
  • Six species commonly found on CPAP masks, laboratory tested: S. aureus, S. epidermidis, P. aeruginosa, K. pneumoniae, S. pyogenes and E.coli, tested with the ResMed AirFit F20 cushion.

HME partners interested in placing commercial orders or requesting onboarding material can contact customer support at [email protected] or [email protected], call (888) 987-0744 or visit www.liviliti.com.