QQJ

Applicator, Negative Pressure, External, Ocular

Product code
QQJ
Device name
Applicator, Negative Pressure, External, Ocular
Device class
Class 2
21 CFR
21 CFR 886.5000
Medical specialty
Ophthalmic
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-04-30.

NumberDecision dateApplicantDevice nameSummary
K2524552026-04-30Balance Ophthalmics, Inc.FSYX Ocular Pressure Adjusting PumpPDF
DEN2300552024-06-27Balance Ophthalmics, Inc.FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) Sy…

1 summaries are archived here for direct download.

Official FDA classification page: QQJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).