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FDA PMA

intraocular lens

PMA Number: P190018 · 2026-04-30

ApplicantAlcon Laboratories, LLC
Decision Date2026-04-30
PMA NumberP190018
Product CodeHQL
Device ClassClass 3
Medical SpecialtyO
Regulation Number21 CFR 8
Advisory CommitteeOP

Device Summary

intraocular lens is a medical device manufactured by Alcon Laboratories, LLC. It received FDA Premarket Approval (PMA) on 2026-04-30 under PMA number P190018. The device is classified under FDA product code HQL. It was reviewed by the OP advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of O. It is regulated under 21 CFR Part 8. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to submit clinical trial data demonstrating the safety and effectiveness of the device. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is intraocular lens?

intraocular lens is a medical device that received FDA Premarket Approval (PMA) on 2026-04-30. It is manufactured by Alcon Laboratories, LLC. The PMA number is P190018.

When did intraocular lens receive FDA PMA approval?

intraocular lens received FDA PMA approval on 2026-04-30, under approval number P190018.

What company makes intraocular lens?

intraocular lens is manufactured by Alcon Laboratories, LLC.

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to provide clinical data proving safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for intraocular lens?

The FDA product code for intraocular lens is HQL.

What FDA device class is intraocular lens?

intraocular lens is classified as Class III by the FDA.

Related Devices (Code: HQL)

PMA P930014intraocular lensAlcon Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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