21 CFR 886.5000 — Applicator, Negative Pressure, External, Ocular
Ophthalmic (OP) · Part 886 Subpart F—Therapeutic Devices · § 886.5000
Identification
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. The FSYX Ocular Pressure Adjusting Pump System 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.
Classification Rationale
CLASSIFICATION: II. The device is subject to general controls and special controls as defined in 21 CFR 886.5000.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QQJ | Applicator, Negative Pressure, External, Ocular | 2 | 1 |
Special Controls
QQJ — Applicator, Negative Pressure, External, Ocular
In combination with the general controls of the FD&C Act. the external ocular negative pressure system is subject to the following special controls:
De Novo Order DEN230055
