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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 10-84: ANSI Z80.11-2012, american national standard for ophthalmics - laser systems for corneal reshaping. (Ophthalmic)

Date of Standard: 2012. 
Address of Standards Development Organization:
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED)
Devices Affected:
Laser Systems for Corneal Reshaping
Processes Affected:
510(k), PMA, IDE, PDP, HDE, Design Control Input
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Excimer Laser System Class 3 LZS
FDA Technical Contact:
 Bruce Drum, Ph.D.
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2418
  Silver Spring MD 20993
  301/796-6466
  email: bruce.drum@fda.hhs.gov
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