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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMEL 90 EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantCarl Zeiss Meditec, Inc.
5160 Hacienda Dr.
Dublin, CA 94568
PMA NumberP060004
Supplement NumberS009
Date Received02/26/2025
Decision Date05/23/2025
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
new replacement infrared (IR) light-emitting diodes (LEDs) with subsequent changes to the IR LED Supply Printed Circuit Board Assembly and the IR LED assembly
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