ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore D…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K221889

Identifiers

510(k) Number: K221889 FDA 510(k)
FDA Product Code: LRK FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 872.5570 FDA 510(k)
Regulation Number: 872.5570 FDA 510(k)
Advisory Committee: Dental FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore D… by ProSomnus Sleep Technologies — Class II — FDA_510K — listed in FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K221889	Class II	Active

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Manufacturer

Manufacturer: ProSomnus Sleep Technologies

Sources (1)

FDA 510(k) K221889 24 fields · synced Jun 19, 2026