# DEN230055: FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System

- Pathway: De Novo (Direct)
- Applicant: Balance Ophthalmics, Inc.
- Decided: Jun 27, 2024 after 307 days
- Product code: QQJ (Applicator, Negative Pressure, External, Ocular)
- Device class: 2
- Regulation: 21 CFR 886.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K252455: FSYX Ocular Pressure Adjusting Pump (2026), 0 descendants of its own

## Indications for use
The FSYX™ Ocular Pressure Adjusting Pump is indicated for the reduction of Intraocular Pressure (IOP) during sleep in adult patients with open-angle glaucoma and IOP ≤ 21 mmHg who are currently using or have undergone another IOP-lowering treatment.

Source page: https://510kreport.com/device/DEN230055
Methodology: https://510kreport.com/methodology