| ANSI Z80.11-2012 (R2017) American National Standard for Ophthalmics - Laser Systems for Corneal Reshaping |
| Recognition Number | Ophthalmic |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 10-84 |
| Extent | Complete standard |
| Standards Orgs | ANSI American National Standards Institute https://www.ansi.org/ |
| STG | Ophthalmic |
| FDA Tech | Bruce Drum FDA/OMPT/CDRH/ODE/DOED/DSDB/ 301-796-6466 bruce.drum@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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 necessary for this type of device.
| Regulation Number | Device Name | Device Class | Product Code |
| Unclassified | Excimer Laser System | Class 3 | LZS |
| There is no relevant guidance published at this time. |