Recognized standard
Z80.1-2020
FDA recognition 10-140 · ANSI · Ophthalmic
Key facts
| Recognition number | 10-140 |
|---|---|
| Designation | Z80.1-2020 |
| Title | American National Standard for Ophthalmics - Prescription Ophthalmic Lenses - Recommendations |
| Standards developer | American National Standards Institute |
| Specialty area | Ophthalmic |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard applies to all prescription dress ophthalmic spectacle lenses in edged or assembled form. It is a guideline for entities that fabricate, assemble or process dress eyewear or lens components. Relevant optical and physical specifications and tolerances of this standard also apply to… |
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: