Light Adjustable Lens and Light Delivery Device

FDA PMA

Class III (US FDA PMA)

PMA P160055

by Rxsight, Inc.

Identity

Trade Name: LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) FDA PMA
Generic Name: Light adjustable lens (LAL) and light delivery device (LDD) FDA PMA

Identifiers

PMA Number: P160055 FDA PMA
FDA Product Code: PZK FDA PMA

Classification

Device Class: Class III FDA PMA
Legislation / Framework: 21 CFR Part 886.3600 FDA PMA
Regulation Number: 886.3600 FDA PMA
Advisory Committee: Ophthalmic FDA PMA
FDA Decision: APPR Approved FDA PMA

The Light Adjustable Lens and Light Delivery Device is an ophthalmic system designed for the reduction of residual astigmatism to improve uncorrected visual acuity. It is intended for use in adult patients following the removal of a cataractous natural lens by phacoemulsification and the subsequent implantation of the intraocular lens into the capsular bag. The system also functions to reduce the likelihood of clinically significant residual spherical refractive errors.

This device is indicated for patients with pre-existing corneal astigmatism of 0.75 diopters or greater who do not have pre-existing macular disease. The system has received FDA PMA approval for its clinical application. It is manufactured by RxSight, Inc. and is categorized under ophthalmic medical devices.

Frequently asked questions

What is the primary purpose of the Light Adjustable Lens and Light Delivery Device?

The system is designed to reduce residual astigmatism and spherical refractive errors in adult patients to improve uncorrected visual acuity after cataract surgery.

Which patients are candidates for this device?

Candidates are adult patients who have undergone cataract removal and lens implantation, specifically those with pre-existing corneal astigmatism of at least 0.75 diopters and no pre-existing macular disease.

Has this device received regulatory authorization?

Yes, the Light Adjustable Lens and Light Delivery Device system has received FDA PMA approval for its indicated use in ophthalmic procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Home | Light Adjustable Lens from RxSight, Study Details | NCT05202808 | RxSight Light Adjustable Lens ..., The Light Adjustable Lens with the RxSight, Clinical outcomes of the light-adjustable lens in eyes with a ..., FDA approves first implanted lens that can be adjusted after ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Pending data

MDR

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA PMA	European Union	MDR	—	Class III	Pending data
FDA PMA	United States	FDA_PMA	P160055	Class III	Active

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Manufacturer

Manufacturer: Rxsight, Inc.

Sources (1)

FDA PMA P160055 24 fields · synced Sep 18, 2026