Qcellus Laser, Activis Laser, ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT Slit Lamp Adapters
FDA premarket approval P050026/S002 · decided 2023-01-20
Approval details
- PMA number
- P050026
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Qcellus Laser, Activis Laser, ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT Slit Lamp Adapters
- Generic name
- System, laser, photodynamic therapy
- Applicant
- Bausch + Lomb Ireland Limited
- Date received
- 2020-09-04
- Decision date
- 2023-01-20
- Days to decision
- 868 days
- Decision code
- APPR
- Product code
- MVF
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Bridgewater, NJ
- 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; and3) Add the following manufacturing facility where Modulight ML6710i Laser and ML-SLA are produced:Modulight, Inc.Hermiankatu 22, Tampere, 33720 FINLAND
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