CT LUCIA Intraocular lens (Model 611P)

FDA Premarket Approval P100016 S008

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for a new product model, ct lucia 611p, which is a design change to the currently approved product ct lucia 602.

DeviceCT LUCIA Intraocular lens (Model 611P)
Generic NameIntraocular Lens
ApplicantCarl Zeiss Meditec Production LLC
Date Received2020-09-08
Decision Date2021-07-08
PMAP100016
SupplementS008
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Carl Zeiss Meditec Production LLC 1040 South Vintage Avenue, Bldg. A ontario, CA 91761-3631

Supplemental Filings

Supplement NumberDateSupplement Type
P100016Original Filing
S008 2020-09-08 Normal 180 Day Track
S007 2020-08-31 135 Review Track For 30-day Notice
S006 2018-08-24 30-day Notice
S005 2018-02-08 30-day Notice
S004 2017-05-22 Normal 180 Day Track No User Fee
S003 2017-03-24 Special (immediate Track)
S002 2014-12-18 Normal 180 Day Track No User Fee
S001 2013-02-19 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
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