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FDA PMA

Excimer laser system

PMA Number: P060004 · 2026-04-30

ApplicantCarl Zeiss Meditec, Inc.
Decision Date2026-04-30
PMA NumberP060004
Product CodeLZS
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeOP

Device Summary

Excimer laser system is a medical device manufactured by Carl Zeiss Meditec, Inc.. It received FDA Premarket Approval (PMA) on 2026-04-30 under PMA number P060004. The device is classified under FDA product code LZS. 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 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 Excimer laser system?

Excimer laser system is a medical device that received FDA Premarket Approval (PMA) on 2026-04-30. It is manufactured by Carl Zeiss Meditec, Inc.. The PMA number is P060004.

When did Excimer laser system receive FDA PMA approval?

Excimer laser system received FDA PMA approval on 2026-04-30, under approval number P060004.

What company makes Excimer laser system?

Excimer laser system is manufactured by Carl Zeiss Meditec, Inc..

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 Excimer laser system?

The FDA product code for Excimer laser system is LZS.

What FDA device class is Excimer laser system?

Excimer laser system 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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