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510(k) K202529

ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring by Prosomnus Sleep Technologies, Inc. — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2020
Date Received
September 1, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Anti-Snoring
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type

Other clearances by Prosomnus Sleep Technologies, Inc.

  • K252765 — ProSomnus RPMO2 OSA Device (RPMO2 OSA) (April 6, 2026)
  • K221889 — ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore De (October 6, 2022)

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  • K252531 — Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) (March 2, 2026)
  • K252976 — Park Dental Nylon MAD (December 18, 2025)
  • K253868 — QuietLab Pro (December 5, 2025)
  • K252161 — Hushd Avera (November 25, 2025)
  • K252525 — AIO Breathe (November 6, 2025)
  • K252698 — NightGuard Aire Max (November 3, 2025)
  • K253355 — Difiney Advanced Anti Snoring Device 4.0 (October 29, 2025)
  • K251784 — Hushd Pro Z-Link (October 24, 2025)