Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Device, Anti-Snoring
510(k) Number K253868
Device Name QuietLab Pro
Applicant
QuietLab, LLC
447 Broadway 2530, 2nd Floor
New York,  NY  10013
Applicant Contact Candriella Pietro
Correspondent
Beanstock Consulting
8885 Rio San Diego Dr. #237
San Diego,  CA  92108
Correspondent Contact Eileen Heller
Regulation Number872.5570
Classification Product Code
LRK  
Date Received12/03/2025
Decision Date 12/05/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-