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.
| Device | Qcellus Laser, Activis Laser, ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT Slit Lamp Adapters |
| Generic Name | System, Laser, Photodynamic Therapy |
| Applicant | Bausch + 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 Received | 2020-09-04 |
| Decision Date | 2023-01-20 |
| PMA | P050026 |
| Supplement | S002 |
| Product Code | MVF |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Bausch + 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 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050026 | Original Filing | |
| S002 | 2020-09-04 | Normal 180 Day Track |
| S001 | 2012-11-19 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 06429810677020 | P050026 | 002 |