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

Applicator, Negative Pressure, External, Ocular

21 CFR 886.5000 / Ophthalmic
FDA source (opens on fda.gov)

QQJ is the FDA product code for Applicator, Negative Pressure, External, Ocular, a class II device type, regulated under 21 CFR 886.5000. FDA's definition for this code reads: "External ocular negative pressure system. An external ocular negative pressure system uses hardware and software to create negative pressure in front of the eye to temporarily lower intraocular pressure in glaucoma patients". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QQJ
Device name
Applicator, Negative Pressure, External, Ocular
FDA definition
External ocular negative pressure system. An external ocular negative pressure system uses hardware and software to create negative pressure in front of the eye to temporarily lower intraocular pressure in glaucoma patients.
Regulation
21 CFR 886.5000
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 QQJ

By decision year
2 clearances under product code QQJ with a decision year between 2024 and 2026, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QQJ by decision year
YearClearances
20241
20261

Applicants with the most clearances

Product code QQJ
Applicants holding the most 510(k) clearances under product code QQJ
ApplicantClearances
Balance Ophthalmics, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code