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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Recognition 09/17/2018 
FR Recognition Number 10-84
Standard
ANSI Z80.11-2012 (R2017)
American National Standard for Ophthalmics - Laser Systems for Corneal Reshaping
Scope/Abstract
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.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
Unclassified Excimer Laser System Class 3 LZS
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance published at this time.
FDA Technical Contact
 Bruce Drum
  FDA/OMPT/CDRH/ODE/DOED/DSDB/
  301-796-6466
  bruce.drum@fda.hhs.gov
Standards Development Organization
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Ophthalmic
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