PMA P200020S007

Device
MFK IOL
Applicant
Lenstec, Inc.
PMA number
P200020
Supplement
S007
Product code
MFK
Decision date
2024-10-11
Classification
Ophthalmic
Generic name
Lens, multifocal intraocular
Approval order statement
to automate the currently manual vial capper process for your HQL and MFK products

Current openFDA PMA Record#

Device
MFK IOL
Applicant
Lenstec, Inc.
PMA number
P200020
Supplement
S007
Product code
MFK
Generic name
Lens, multifocal intraocular
Decision date
2024-10-11
Decision code
OK30
Date received
2024-09-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
to automate the currently manual vial capper process for your HQL and MFK products