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FDA PMA

Artificial iris

PMA Number: P170039 · 2020-09-04

ApplicantHumanoptics AG
Decision Date2020-09-04
PMA NumberP170039
Product CodeQBT
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeOP

Device Summary

Artificial iris is the device name listed in this FDA PMA record. The listed applicant is Humanoptics AG. It received FDA Premarket Approval (PMA) on 2020-09-04 under PMA number P170039. The device is classified under FDA product code QBT. 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 U. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. 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 Artificial iris?

Artificial iris is a medical device that received FDA Premarket Approval (PMA) on 2020-09-04. The listed applicant is Humanoptics AG. The PMA number is P170039.

When did Artificial iris receive FDA PMA approval?

Artificial iris received FDA PMA approval on 2020-09-04, under PMA number P170039.

Who is the listed applicant for Artificial iris?

The FDA PMA record lists Humanoptics AG as the applicant. This does not by itself establish the device manufacturer.

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 valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for Artificial iris?

The FDA product code for Artificial iris is QBT.

What FDA device class is Artificial iris?

Artificial iris is classified as Class III by the FDA.

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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