Recognized standard
Z80.29-2015 (R2020)
FDA recognition 10-115 · ANSI · Ophthalmic
Key facts
| Recognition number | 10-115 |
|---|---|
| Designation | Z80.29-2015 (R2020) |
| Title | American National Standard for Ophthalmics - Accomodative Intraocular Lenses |
| Standards developer | American National Standards Institute |
| Specialty area | Ophthalmic |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 3 |
| Scope (excerpt) | This standard applies to any ocular implant whose primary indication is the correction of aphakia and is designed to provide vision over a continuous range of distances by affecting a change in the vergence power of the eye resulting from the implant design that changes eye optical power or implant… |
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: