ProSomnus RPMO2 OSA Device (RPMO2 OSA)

ProSomnus RPMO2 OSA Device (RPMO2 OSA) is an FDA 510(k)-cleared medical device (K252765) manufactured by Prosomnus Sleep Technologies. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 5, 2026. Regulation: 8.