PMA P090022S030

Device
LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant
Lenstec, Inc.
PMA number
P090022
Supplement
S030
Product code
HQL
Decision date
2017-01-11
Classification
Intraocular Lens
Generic name
intraocular lens
Approval order statement
Addition of another lens analyzer unit for assessing lens power and quality.

Current openFDA PMA Record#

Device
LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant
Lenstec, Inc.
PMA number
P090022
Supplement
S030
Product code
HQL
Generic name
intraocular lens
Decision date
2017-01-11
Decision code
OK30
Date received
2016-12-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of another lens analyzer unit for assessing lens power and quality.