RxSight Light Adjustable Lens and Light Delivery

FDA Premarket Approval P160055 S017

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) referenced above.

DeviceRxSight Light Adjustable Lens and Light Delivery
Generic NameLight Adjustable Lens (lal) And Light Delivery Device (ldd)
ApplicantRxSight, Inc.
Date Received2021-02-08
Decision Date2021-03-10
PMAP160055
SupplementS017
Product CodePZK 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
Expedited ReviewNo
Combination Product No
Applicant Address RxSight, Inc. 100 Columbia aliso Viejo, CA 92656

Supplemental Filings

Supplement NumberDateSupplement Type
P160055Original Filing
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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00818806020210 P160055 002
00818806020203 P160055 002
00818806020197 P160055 002
00818806020180 P160055 002
00818806020319 P160055 002

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