FDA Product Code QQJ: Applicator, Negative Pressure, External, Ocular
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.
Leading manufacturers include Balance Ophthalmics, Inc..
2
Total
1
Cleared
288d
Avg days
2024
Since
Stable submission activity - 1 submissions in the last 2 years
Consistent review times:
268d avg (recent)
FDA 510(k) Cleared Applicator, Negative Pressure, External, Ocular Devices (Product Code QQJ)
2 devices
Cleared
Apr 30, 2026
FSYX Ocular Pressure Adjusting Pump
Balance Ophthalmics, Inc.
Ophthalmic
268d
Not Cleared
Jun 27, 2024
FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System
Balance Ophthalmics, Inc.
Ophthalmic
307d
About Product Code QQJ - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QQJ since 2024, with 1 receiving FDA clearance (average review time: 288 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - QQJ Product Code
FDA review times for QQJ submissions have been consistent, averaging 268 days recently vs 307 days historically.
QQJ devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →