DeviceClearance

Product code QQJ— Ophthalmic

FSYX Ocular Pressure Adjusting Pump

Classification name
Applicator, Negative Pressure, External, Ocular
Device class
Class 2
Regulation
21 CFR 886.5000
Advisory panel
Ophthalmic
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QQJ under 21 CFR 886.5000, via openFDA

Market context for product code QQJ

FDA has cleared 2 devices under product code QQJ between 2024 and 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QQJ

Recent clearances under product code QQJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.