Recognized standard
Z80.27-2014 (R2019)
FDA recognition 10-93 · ANSI · Ophthalmic
Key facts
| Recognition number | 10-93 |
|---|---|
| Designation | Z80.27-2014 (R2019) |
| Title | American National Standard for Ophthalmics - Implantable Glaucoma Devices |
| Standards developer | American National Standards Institute |
| Specialty area | Ophthalmic |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | The scope of this standard applies to devices that are implanted in the eye to treat glaucoma by facilitating aqueous outflow. The standard excludes glaucoma devices whose effect depends upon metabolic and/or pharmacologic mechanisms. |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: