QCELLUS LASER

FDA Premarket Approval P050026 S001

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

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.

• Device: QCELLUS LASER
• Generic Name: System, Laser, Photodynamic Therapy
• Applicant: Bausch Health Ireland Limited
• Date Received: 2012-11-19
• Decision Date: 2013-09-26
• PMA: P050026
• Supplement: S001
• Product Code: MVF
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: Bausch Health Ireland Limited 208 Val Des Bons Malades grand Duchy Of Luxembourg L-212-2121

Supplemental Filings

Supplement Number	Date	Supplement Type
P050026		Original Filing
S002	2020-09-04	Normal 180 Day Track
S001	2012-11-19	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
06429810677020	P050026	002