Recognized standard
Z80.11-2012 (R2022)
FDA recognition 10-84 · ANSI · Ophthalmic
Key facts
| Recognition number | 10-84 |
|---|---|
| Designation | Z80.11-2012 (R2022) |
| Title | American National Standard for Ophthalmics - Laser Systems for Corneal Reshaping |
| 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 laser system whose primary intended use is to alter the shape of the cornea through the removal of corneal tissue, resulting in the improvement of visual performance. This standard addresses the vocabulary, performance requirements, labeling, and clinical investigations… |
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: