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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.
Classification Namelight adjustable lens (lal) and light delivery device (ldd)
Generic Namelight adjustable lens (lal) and light delivery device (ldd)
Regulation Number886.3600
RxSight, Inc.
100 columbia
aliso viejo, CA 92656
PMA NumberP160055
Date Received12/09/2016
Decision Date11/22/2017
Product Code
PZK[ Registered Establishments with PZK ]
Docket Number 17M-6614
Notice Date 12/05/2017
Advisory Committee Ophthalmic
Clinical Trials NCT00845520
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002 S003 S004 S005 S006 S007