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FDA PRODUCT CODE · CLASS II

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 886.5000
MEDICAL SPECIALTY
Ophthalmic
REVIEW PANEL
OP
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
510k: 1
0
RECALL ENTRIES

Recent clearances

K252455Balance Ophthalmics, Inc. · 510k2026-04-30

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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