Not Cleared Direct

DEN230055 - FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN230055 · Balance Ophthalmics, Inc. · Ophthalmic device
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Jun 2024
Decision
307d
Days
Class 2
Risk

DEN230055 is an FDA 510(k) submission (not cleared) for the FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System. Classified as Applicator, Negative Pressure, External, Ocular (product code QQJ), Class II - Special Controls.

Submitted by Balance Ophthalmics, Inc. (Sioux Falls, US). The FDA issued a Not Cleared (DENG) decision on June 27, 2024 after a review of 307 days.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5000 - the FDA ophthalmic device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 307 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Balance Ophthalmics, Inc. devices

Submission Details

510(k) Number DEN230055 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 25, 2023
Decision Date June 27, 2024
Days to Decision 307 days
Submission Type Direct
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
197d slower than avg
Panel avg: 110d · This submission: 307d
Pathway characteristics

Device Classification

Product Code QQJ Applicator, Negative Pressure, External, Ocular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5000
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.