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510(k) K222872

DNA Appliance by Vivos Therapeutics, Inc. — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2022
Date Received
September 22, 2022
Clearance Type
Traditional
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 Vivos Therapeutics, Inc.

  • K234089 — DNA Appliance (September 16, 2024)
  • K230947 — C.A.R.E. Appliance (DNA, mRNA, mmRNA) (November 28, 2023)

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  • K253355 — Difiney Advanced Anti Snoring Device 4.0 (October 29, 2025)
  • K251784 — Hushd Pro Z-Link (October 24, 2025)
  • K251628 — Mandibular Advancement Device L07 (October 22, 2025)