PMA P050026S001

Device: QCELLUS LASER
Applicant: Bausch + Lomb Ireland Limited
PMA number: P050026
Supplement: S001
Product code: MVF
Decision date: 2013-09-26
Generic name: System, laser, photodynamic therapy
Approval order statement: APPROVAL FOR: 1) CHANGE IN THE NAME OF THE DEVICE FROM ACTIVIS LASER TO QCELLUS LASER; 2) CHANGE IN THE LASER DESIGN TO COMBINE THE LASER MODULE AND SLIT LAMP ADAPTER INTO A SINGLE UNIT TO BE MOUNTED DIRECTLY ON THE TONOMETER POST OF A HAAG-STREIT 900 BM/BQ SLIT LAMP OR EQUIVALENT; AND 3) CHANGE MANUFACTURING SITE FOR THE QCELLUS LASER TO QLT, INC., VANCOUVER, BC, CANADA.

Current openFDA PMA Record#

Device: QCELLUS LASER
Applicant: Bausch + Lomb Ireland Limited
PMA number: P050026
Supplement: S001
Product code: MVF
Generic name: System, laser, photodynamic therapy
Decision date: 2013-09-26
Decision code: APPR
Date received: 2012-11-19
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR: 1) CHANGE IN THE NAME OF THE DEVICE FROM ACTIVIS LASER TO QCELLUS LASER; 2) CHANGE IN THE LASER DESIGN TO COMBINE THE LASER MODULE AND SLIT LAMP ADAPTER INTO A SINGLE UNIT TO BE MOUNTED DIRECTLY ON THE TONOMETER POST OF A HAAG-STREIT 900 BM/BQ SLIT LAMP OR EQUIVALENT; AND 3) CHANGE MANUFACTURING SITE FOR THE QCELLUS LASER TO QLT, INC., VANCOUVER, BC, CANADA.