PMA P990018S009

Device: Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear, ACUVUE® Abiliti Overnight and ACUVUE® Abiliti Overni
Applicant: Menicon Co, Ltd.
Product code: NUU
Decision date: 2023-05-01
Generic name: Lens, contact, orthokeratology, overnight
Approval order statement: Approval for lens parameters ranges for the central base curve radius, tangential angle and sagittal depth.

Current openFDA PMA Record

Device: Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear, ACUVUE® Abiliti Overnight and ACUVUE® Abiliti Overni
Applicant: Menicon Co, Ltd.
PMA number: P990018
Supplement: S009
Product code: NUU
Generic name: Lens, contact, orthokeratology, overnight
Decision date: 2023-05-01
Decision code: APPR
Date received: 2023-01-31
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for lens parameters ranges for the central base curve radius, tangential angle and sagittal depth.