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510(k) K261366

Virtus by Somnomed, Inc. — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2026
Date Received
April 27, 2026
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 Somnomed, Inc.

  • K233497 — Rest Assure System (October 3, 2024)
  • K183443 — SomnoDent Avant (May 8, 2019)
  • K162306 — SomnoDent ALPHA (September 20, 2016)
  • K150369 — SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac M (June 18, 2015)
  • K140278 — SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX (June 20, 2014)
  • K130558 — SOMNODENT HERBST; CLASSIC, FLEX (May 17, 2013)
  • K121340 — SOMNODENT G2 (May 30, 2012)
  • K102909 — SOMNOBRUX SPLINTS (December 13, 2011)
  • K102521 — PANTINO PRO POSITINER (March 28, 2011)
  • K073004 — SOMNOMED BFLEX (January 30, 2008)

Other clearances for product code LRK

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  • K261134 — Dormiva Anti-Snoring Mouth Guard (May 14, 2026)
  • K252942 — ShaeferH (April 10, 2026)
  • K253845 — Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) (March 3, 2026)
  • 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)