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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.
 
DeviceQuantel Activis Laser, Modulight ML6710i Laser and ML-SLA, ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT Slit Lamp Adapters
Generic NameSystem, laser, photodynamic therapy
ApplicantBausch + Lomb Ireland Limited
400 Somerset Corporate Blvd.
Bridgewater, NJ 08807
PMA NumberP050026
Supplement NumberS003
Date Received11/12/2024
Decision Date02/11/2025
Product Code MVF 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of changes to a photodiode and optical system of the slit-lamp adapter of the Modulight ML6710i Laser.
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