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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.
 
DeviceQcellus Laser, Activis Laser, 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 NumberS002
Date Received09/04/2020
Decision Date01/20/2023
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 for the following changes:1) Add a new laser source, Modulight ML6710i Laser, and the related slit-lamp adapter, ML-SLA;2) Change the device name to Quantel Activis Laser, Modulight ML6710i Laser and ML-SLA, ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT Slit Lamp Adapters; and3) Add the following manufacturing facility where Modulight ML6710i Laser and ML-SLA are produced:Modulight, Inc.Hermiankatu 22, Tampere, 33720 FINLAND
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