Recognized standard
Z80.35-2018
FDA recognition 10-116 · ANSI · Ophthalmic
Key facts
| Recognition number | 10-116 |
|---|---|
| Designation | Z80.35-2018 |
| Title | American National Standard for Ophthalmics - Extended Depth of Focus Intraocular Lenses |
| Standards developer | American National Standards Institute |
| Specialty area | Ophthalmic |
| Date of entry | Jul 15, 2019 |
| Device classes | Class 3 |
| Scope (excerpt) | This standard applies to intraocular lenses (IOLs) whose function is the correction of aphakia, with extended range of focus above a defined functional visual acuity threshold to provide useful distance and intermediate vision with monotonically decreasing visual acuity from the best distance focal… |
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: