PMA P080004

Device: iSert Preloaded IOL System: iSert 250, iSert 251, iSert 230, iSert 231, IPure™ Preloaded IOL System / Model B1PC (Clear
Applicant: Hoya Surgical Optics, Inc.
PMA number: P080004
Supplement: S043
Product code: HQL
Decision date: 2023-10-25
Generic name: intraocular lens
Approval order statement: Approval for a button manufacturing site located at HOYA Lamphun Ltd., 75/2 Moo 4, Tambol Banklang, Amphur, Muang, Lamphun, 51000, Thailand

Current openFDA PMA Record#

Device: iSert Preloaded IOL System: iSert 250, iSert 251, iSert 230, iSert 231, IPure™ Preloaded IOL System / Model B1PC (Clear
Applicant: Hoya Surgical Optics, Inc.
PMA number: P080004
Supplement: S047
Product code: HQL
Generic name: intraocular lens
Decision date: 2023-10-25
Decision code: APPR
Date received: 2023-08-29
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a button manufacturing site located at HOYA Lamphun Ltd., 75/2 Moo 4, Tambol Banklang, Amphur, Muang, Lamphun, 51000, Thailand