Recognized standard
Z80.13-2007 (R2022)
FDA recognition 10-57 · ANSI · Ophthalmic
Key facts
| Recognition number | 10-57 |
|---|---|
| Designation | Z80.13-2007 (R2022) |
| Title | American National Standard for Ophthalmics - Phakic Intraocular Lenses |
| Standards developer | American National Standards Institute |
| Specialty area | Ophthalmic |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 3 |
| Scope (excerpt) | This standard applies to any intraocular lens (IOL) whose primary indication is the modification of the refractive power of a phakic eye. It does not include IOLs used to correct presbyopia or astigmatism. |
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: