Luna G3 Auto BPAP Receives 510(k) Clearance

New bi-level PAP therapy device represents 3B Medical's third generation platform and includes algorithm that senses and adjusts pressure settings to ensure airway patency.

• By David Kopf
• Feb 04, 2021

Sleep therapy equipment maker 3B Medical Inc. has received FDA 510(k) clearance on its new, third-generation bi-level device, the Luna G3 Auto-BPAP. 

The Luna G3 Auto BPAP is a Bi-Level PAP therapy device for the treatment of obstructive sleep apnea that features integrated heated tubing, cellular connectivity, and 3B’s advanced algorithm, which automatically senses and adjusts pressure settings to ensure airway patency for a comfortable night’s sleep. Also, the Luna G3 Auto- BPAP provides a backup rate that reduces the work of breathing with pressure settings up to 25 cmH20. 

“We are excited by FDA’s recent action approving use of the Lumin G3 Auto-BPAP”, said Justin Smith, 3B Medical’s Chief Operating Officer. “The Luna G3 is 3B Medical’s third-generation platform and incorporates a new design, a smaller footprint, and more advanced functionality. The Luna G3 Auto-BPAP delivers non-invasive ventilatory support with all of the bells and whistles that DME’s have come to expect from 3B Medical.”