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 Masker, Tinnitus
510(k) Number K260413
Device Name Levo Gen 2 Tinnitus Therapy System
Applicant
Levo Medical Corporation
455 Boleskine Rd.
Victoria, Bc,  CA V8Z1E7
Applicant Contact Matt Lopez
Correspondent
SpringRA, Inc.
325 Betty Ann Dr.
North York,  CA M2R 1B4
Correspondent Contact Tal Bersler Stramer
Regulation Number874.3400
Classification Product Code
KLW  
Date Received02/09/2026
Decision Date 08/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-