Recognized standard
15798 Fourth edition 2022-01
FDA recognition 10-131 · ISO · Ophthalmic
Key facts
| Recognition number | 10-131 |
|---|---|
| Designation | 15798 Fourth edition 2022-01 |
| Title | Ophthalmic implants - Ophthalmic viscosurgical devices |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | May 30, 2022 |
| Device classes | Class 3 |
| Scope (excerpt) | This document is applicable to ophthalmic viscosurgical devices (OVDs), a class of surgical invasive medical devices with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect… |
At a glance
- None 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: