510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260413Substantially Equivalent

Levo Gen 2 Tinnitus Therapy System

Levo Medical Corporation, Victoria, Bc, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K260413 is the FDA 510(k) clearance record for Levo Gen 2 Tinnitus Therapy System, a class II device, cleared for Levo Medical Corporation on under FDA product code KLW (Masker, Tinnitus). FDA records list one 510(k) clearance for Levo Medical Corporation. As of , FDA records show no recalls naming K260413.

Clearance record

Decision date
Received
(185 days to decision)
Product code
KLW Masker, Tinnitus
Regulation
21 CFR 874.3400
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Levo Medical Corporation 455 Boleskine Rd., Victoria, Bc, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KLW

Trailing 12 months
2 clearances under product code KLW in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KLW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260