QCELLUS LASER
FDA premarket approval P050026/S001 · decided 2013-09-26
Approval details
- PMA number
- P050026
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- QCELLUS LASER
- Generic name
- System, laser, photodynamic therapy
- Applicant
- Bausch + Lomb Ireland Limited
- Date received
- 2012-11-19
- Decision date
- 2013-09-26
- Days to decision
- 311 days
- Decision code
- APPR
- Product code
- MVF
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Bridgewater, NJ
- 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.
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