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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceLIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD)
Generic NameLight adjustable lens (LAL) and light delivery device (LDD)
Regulation Number886.3600
ApplicantRxsight, Inc.
100 Columbia
Aliso Viejo, CA 92656
PMA NumberP160055
Date Received12/09/2016
Decision Date11/22/2017
Product Code PZK 
Docket Number 17M-6614
Notice Date 12/05/2017
Advisory Committee Ophthalmic
Clinical TrialsNCT00845520
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for The Light Adjustable Lens and Light Delivery Device system is indicated for the reduction residual astigmatism to improve uncorrected visual acuity after removal of the cataractous natural lens by phacoemulsification and implantation of the intraocular lens in the capsular bag, in adult patients: 1) With pre-existing corneal astigmatism of => 0.75 diopters; and 2) Without pre-existing macular disease. The system also reduces the likelihood of clinically significant residual spherical refractive errors.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S008 S004 S014 S006 S016 S023 S021 S024 S025 S026 S032 
S042 S038 S039 S044 S045 S046 S052 S040 S034 S002 S007 S035 
S037 S031 S051 S043 S015 S003 S009 S010 S011 S005 S019 S054 
S055 S017 S018 S022 S027 S028 S029 S047 S048 S033 S041 
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