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Dishler Excimer Laser Systems

by Dtc Eye Surgery Center PMA

Withdrawn United States

PMA P970049

Overview

The Dishler Excimer Laser System is an excimer laser device classified as a corneal refractive surgery instrument. It is designed for use in LASIK procedures to reshape the cornea and correct myopia (nearsightedness) ranging from -0.5 to -13.0 diopters (D) with or without astigmatism between -0.5 D and -4.0 D. The system employs ultraviolet laser technology to precisely ablate corneal tissue, enabling refractive error correction in eligible patients.

This device is supplied by Dtc Eye Surgery Center and is intended for use in clinical settings by trained ophthalmologists. It is a reusable medical instrument, regulated under FDA Premarket Approval (PMA) with approval number P970049. The system requires proper maintenance, calibration, and adherence to sterile protocols in operating environments. No specific MRI safety classification or single-use designation is noted in the data.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

Withdrawn since 16 Dec 1999. The authorization below is no longer in force.

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP970049 Date16 Dec 1999Approval withdrawnStatusWithdrawn

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA PMA Withdrawn

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

PMA

PMA Number
Advisory Committee
Neurology
FDA Decision
APWD Approval withdrawn

Questions

  • What types of vision corrections can the Dishler Excimer Laser System address, and what age group is it approved for?

    The Dishler Excimer Laser System is designed to correct myopia (nearsightedness) ranging from -0.5 to -13.0 diopters, with or without astigmatism between -0.5 and -4.0 diopters. It is specifically approved for use in patients aged 21 years or older, as indicated by the FDA Premarket Approval (PMA) authorization. The system is intended for reshaping the cornea to reduce or eliminate refractive errors in eligible patients.

  • Is the Dishler Excimer Laser System intended for single-use or reusable applications, and what maintenance is required?

    The Dishler Excimer Laser System is a reusable medical instrument, not designated for single-use. Since it is used in clinical settings for corneal refractive surgery, it requires proper maintenance, calibration, and adherence to sterile protocols in operating environments to ensure safety and effectiveness.

  • What specific patient criteria must be met for eligibility when using the Dishler Excimer Laser System?

    Eligible patients must be 21 years or older with myopia ranging from -0.5 to -13.0 diopters, with or without astigmatism between -0.5 and -4.0 diopters. Additionally, patients must demonstrate stable refractive error for at least one year prior to the procedure, showing changes of no more than 0.5 diopters in either the sphere or cylinder components.

  • How is the Dishler Excimer Laser System regulated, and what approval number is associated with it?

    The Dishler Excimer Laser System is regulated under the FDA Premarket Approval (PMA) pathway, with approval number P970049. This classification ensures the device meets stringent regulatory standards for safety and effectiveness before clinical use.