510 (k) Premarket Notification Approval

Premarket approval by the FDA is a regulatory approval process that allows the manufacturer to market and distribute the device within the US. The following premarket approvals were issued recently:
 
 
Device Name Product Code Applicant Decision Date Indications for Use
Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) LRK Myofunctional Research Co. 3/2/2026 RX: The Myosa (S1H, S1, S1M, S2, S2M, S3) appliances are intended to treat snoring and/or mild to moderate obstructive sleep apnea in adults at least 18 years old.
 
OTC: The Myosa for Snorers (S1, S1M and S2) are intended to treat snoring in adults at least 18 years old.
Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) LRK Ram.Shaw Pte. , Ltd 3/3/2026 The Anti Snoring Mouthpiece is designed to advance the user's lower jawandmaintain this position during use, opening the airway to reduce snoring during sleep. It is intended for adults with at least 18 years old.
ProSomnus RPMO2 OSA Device (RPMO2 OSA) DQA, LQZ, LRK, PLC, and OUG Prosomnus Sleep Technologies 4/6/2026 The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device. It is indicated for the treatment of snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adults.
 
 
To search for the full list of devices that are FDA-cleared, visit the FDA’s 510 (k) Premarket Notification database and search using product code LQZ (Device, jaw repositioning) or LRK (Device, anti-snoring).
 
To see the indications for use of a cleared appliance:
  • Click on the appliance’s name in the database’s search results
  • Click on the linked summary for the device to see a summary of the indications for use, FDA’s approval letter, and the manufacturer’s application letter