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

Electromechanical Tear Stimulator

21 CFR 886.5305 / Ophthalmic
FDA source (opens on fda.gov)

QKV is the FDA product code for Electromechanical Tear Stimulator, a class II device type, regulated under 21 CFR 886.5305. FDA's definition for this code reads: "This device type is a non-implantable device intended to increase tear production via mechanical stimulation". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QKV
Device name
Electromechanical Tear Stimulator
FDA definition
This device type is a non-implantable device intended to increase tear production via mechanical stimulation.
Regulation
21 CFR 886.5305
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QKV

By decision year
2 clearances under product code QKV with a decision year between 2020 and 2022, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QKV by decision year
YearClearances
20201
20221

Applicants with the most clearances

Product code QKV
Applicants holding the most 510(k) clearances under product code QKV
ApplicantClearances
Olympic Ophthalmics2

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QKV.