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510(k) K250482

Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue by Fissiontech, LLC — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2025
Date Received
February 19, 2025
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 Fissiontech, LLC

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  • 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)
  • K251628 — Mandibular Advancement Device L07 (October 22, 2025)