510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN190026Unknown

iTEAR Neurostimulator

Olympic Ophthalmics, Issaquah WA / Direct, Unknown
FDA source (opens on fda.gov)

DEN190026 is the FDA 510(k) clearance record for iTEAR Neurostimulator, a class II device, cleared for Olympic Ophthalmics, Inc. on under FDA product code QKV (Electromechanical Tear Stimulator). FDA's definition for product code QKV reads: "This device type is a non-implantable device intended to increase tear production via mechanical stimulation". FDA records list 2 510(k) clearances for Olympic Ophthalmics, Inc., from to . As of , FDA records show no recalls naming DEN190026.

Clearance record

Decision date
Received
(352 days to decision)
Product code
QKV Electromechanical Tear Stimulator
Regulation
21 CFR 886.5305
Device class
Class II
Review panel
Ophthalmic
Applicant
Olympic Ophthalmics, Inc. 400 NW Gilman Blvd. #1370, Issaquah WA
Third party review
No

Clearances, product code QKV

Trailing 12 months

FDA records hold no clearances under product code QKV in the trailing twelve months.

FDA records show no clearances under product code QKV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QKV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260