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510(k) K262104

Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT) by Ram.Shaw Pte., Ltd. — Product Code LRK

K262104 is an FDA 510(k) premarket notification submitted by Ram.Shaw Pte., Ltd. for the device "Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)". The FDA issued a decision of Substantially Equivalent on August 27, 2026. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2026
Date Received
June 23, 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 for product code LRK

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  • K261366 — Virtus (June 12, 2026)
  • K261251 — Snorbliss® Anti-Snoring Device (June 11, 2026)
  • 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)

FDA data resources