PMA P090022

Device: Softec HD; Softec I; Softec HD PS; Softec HDO; Softec HDM
Applicant: Lenstec, Inc.
PMA number: P090022
Supplement: S039
Product code: HQL
Decision date: 2026-04-15
Generic name: intraocular lens
Approval order statement: the addition of a new moist heat (steam) sterilizer, and associated increased maximum sterilization load size, for routine terminal sterilization of the subject intraocular lens devices

Current openFDA PMA Record#

Device: Softec HD; Softec I; Softec HD PS; Softec HDO; Softec HDM
Applicant: Lenstec, Inc.
PMA number: P090022
Supplement: S049
Product code: HQL
Generic name: intraocular lens
Decision date: 2026-04-15
Decision code: OK30
Date received: 2026-03-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the addition of a new moist heat (steam) sterilizer, and associated increased maximum sterilization load size, for routine terminal sterilization of the subject intraocular lens devices