Light Adjustable Lens (LAL) and Light Delivery (LDD)

Light Adjustable Lens (lal) And Light Delivery Device (ldd)

FDA Premarket Approval P160055 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 additional qualified coupling agents and uv protective eyewear to be used with the lal/ldd

DeviceLight Adjustable Lens (LAL) and Light Delivery (LDD)
Classification NameLight Adjustable Lens (lal) And Light Delivery Device (ldd)
Generic NameLight Adjustable Lens (lal) And Light Delivery Device (ldd)
ApplicantRxSight, Inc.
Date Received2019-09-13
Decision Date2019-11-22
PMAP160055
SupplementS008
Product CodePZK
Advisory CommitteeOphthalmic
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address RxSight, Inc. 100 Columbia aliso Viejo, CA 92656

Supplemental Filings

Supplement NumberDateSupplement Type
P160055Original Filing
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
00818806020029 P160055 000
00818806020159 P160055 002
00818806020142 P160055 002
00818806020135 P160055 002
00818806020128 P160055 002
00818806020111 P160055 002
00818806020104 P160055 002
00818806020098 P160055 002
00818806020081 P160055 002
00818806020074 P160055 002
00818806020067 P160055 002
00818806020050 P160055 002
00818806020043 P160055 002
00818806020036 P160055 002
00818806020166 P160055 002
00818806020173 P160055 002
00818806020302 P160055 002
00818806020296 P160055 002
00818806020289 P160055 002
00818806020272 P160055 002
00818806020265 P160055 002
00818806020258 P160055 002
00818806020241 P160055 002
00818806020234 P160055 002
00818806020227 P160055 002
00818806020210 P160055 002
00818806020203 P160055 002
00818806020197 P160055 002
00818806020180 P160055 002
00818806020319 P160055 002

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