PMA P080011S186

Device: iWear oxygen presbyopia
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S186
Product code: LPM
Decision date: 2025-08-20
Classification: Ophthalmic
Generic name: Lenses, soft contact, extended wear
Approval order statement: approval for labeling change to add new private label brand name, iWear oxygen presbyopia. The name iWear oxygen presbyopia is intended for the multifocal lens design

Current openFDA PMA Record#

Device: iWear oxygen presbyopia
Applicant: CooperVision, Inc.
PMA number: P080011
Supplement: S186
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2025-08-20
Decision code: APPR
Date received: 2025-03-14
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for labeling change to add new private label brand name, iWear oxygen presbyopia. The name iWear oxygen presbyopia is intended for the multifocal lens design