Light Adjustable Lens, Light Delivery

FDA Premarket Approval P160055 S021

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 of the revised protocol for the post-approval study (pas) protocol.

DeviceLight Adjustable Lens, Light Delivery
Generic NameLight Adjustable Lens (lal) And Light Delivery Device (ldd)
ApplicantRxSight, Inc.
Date Received2021-09-10
Decision Date2021-10-05
PMAP160055
SupplementS021
Product CodePZK 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination Product No
Applicant Address RxSight, Inc. 100 Columbia aliso Viejo, CA 92656

Supplemental Filings

Supplement NumberDateSupplement Type
P160055Original Filing
S021 2021-09-10 Normal 180 Day Track No User Fee
S020
S019 2021-03-04 30-day Notice
S018 2021-02-25 30-day Notice
S017 2021-02-08 Normal 180 Day Track No User Fee
S016 2020-11-27 Real-time Process
S015
S014
S013
S012
S011 2020-02-27 Real-time Process
S010
S009 2020-01-30 Normal 180 Day Track No User Fee
S008 2019-09-13 Real-time Process
S007 2019-08-19 30-day Notice
S006 2019-05-23 30-day Notice
S005
S004 2019-03-06 30-day Notice
S003 2018-11-07 Normal 180 Day Track No User Fee
S002 2018-09-05 Normal 180 Day Track
S001

NIH GUDID Devices

Device IDPMASupp
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