PMA P050026S003

Device: Quantel Activis Laser, Modulight ML6710i Laser and ML-SLA, ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT Slit Lamp Adapters
Applicant: Bausch + Lomb Ireland Limited
PMA number: P050026
Supplement: S003
Product code: MVF
Decision date: 2025-02-11
Classification: Ophthalmic
Generic name: System, laser, photodynamic therapy
Approval order statement: Approval of changes to a photodiode and optical system of the slit-lamp adapter of the Modulight ML6710i Laser.

Current openFDA PMA Record#

Device: Quantel Activis Laser, Modulight ML6710i Laser and ML-SLA, ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT Slit Lamp Adapters
Applicant: Bausch + Lomb Ireland Limited
PMA number: P050026
Supplement: S003
Product code: MVF
Generic name: System, laser, photodynamic therapy
Decision date: 2025-02-11
Decision code: APPR
Date received: 2024-11-12
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval of changes to a photodiode and optical system of the slit-lamp adapter of the Modulight ML6710i Laser.