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..
FDA 510(k) Cleared Applicator, Negative Pressure, External, Ocular Devices (Product Code QQJ)
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 increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
QQJ devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →