PMA P180035S033

Device: MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Applicant: CooperVision, Inc.
PMA number: P180035
Supplement: S033
Product code: QIT
Decision date: 2025-12-23
Classification: Ophthalmic
Generic name: Daily wear soft contact lens to reduce the progression of myopia
Approval order statement: introduction of a refurbished 32 impression strip blister tool to be used in an injection moulding machine of an approved blister manufacturer

Current openFDA PMA Record#

Device: MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Applicant: CooperVision, Inc.
PMA number: P180035
Supplement: S033
Product code: QIT
Generic name: Daily wear soft contact lens to reduce the progression of myopia
Decision date: 2025-12-23
Decision code: OK30
Date received: 2025-12-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: introduction of a refurbished 32 impression strip blister tool to be used in an injection moulding machine of an approved blister manufacturer