Quantel Activis Laser, Modulight ML6710i Laser and ML-SLA, ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT Slit Lamp Adapters
FDA premarket approval P050026/S003 · decided 2025-02-11
Approval details
- PMA number
- P050026
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Quantel Activis Laser, Modulight ML6710i Laser and ML-SLA, ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT Slit Lamp Adapters
- Generic name
- System, laser, photodynamic therapy
- Applicant
- Bausch + Lomb Ireland Limited
- Date received
- 2024-11-12
- Decision date
- 2025-02-11
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- MVF
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Bridgewater, NJ
- Statement
- Approval of changes to a photodiode and optical system of the slit-lamp adapter of the Modulight ML6710i Laser.
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