Qcellus Laser, Activis Laser, ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT Slit Lamp Adapters

FDA Premarket Approval P050026 S002

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.

Pre-market Approval Supplement Details

DeviceQcellus Laser, Activis Laser, ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT Slit Lamp Adapters
Generic NameSystem, Laser, Photodynamic Therapy
ApplicantBausch + Lomb Ireland Limited400 Somerset Corporate Blvdbridgewater, 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
Date Received2020-09-04
Decision Date2023-01-20
PMAP050026
SupplementS002
Product CodeMVF 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductYes
Applicant AddressBausch + 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 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”.3. Add The Following Manufacturing Facility Where Modulight ML6710i Laser And ML-SLA Are Produced:Modulight, Inc.Hermiankatu 22, Tampere, 33720 FINLAND

Supplemental Filings

Supplement NumberDateSupplement Type
P050026Original Filing
S002 2020-09-04 Normal 180 Day Track
S001 2012-11-19 Normal 180 Day Track

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