Identity
- Trade Name
- TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z) FDA PMA
- Generic Name
- Excimer laser system FDA PMA
Identifiers
- PMA Number
- P990027 FDA PMA
- FDA Product Code
- LZS FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Technolas 217Z Zyoptix System is an excimer laser system classified as a Class III medical device. It is designed to perform Laser In-Situ Keratomileusis (LASIK) for the correction of myopia (nearsightedness) between -1.00 and -7.00 diopters with less than -3.00 diopters of astigmatism, under specific patient stability criteria.
This device is intended for use in ophthalmic surgical settings by trained professionals. It is a reusable system with FDA approval under PMA number P990027, and its application is restricted to patients aged 21 years or older with documented refractive stability for at least 12 months prior to treatment. No information regarding sterility, MRI safety, or specific storage conditions is provided in the data.
Frequently asked questions
What specific refractive errors can the Technolas 217Z Zyoptix System correct, and what patient criteria must be met before treatment?
The Technolas 217Z Zyoptix System is designed to correct myopia (nearsightedness) ranging from -1.00 to -7.00 diopters, with less than -3.00 diopters of astigmatism. Treatment is restricted to patients aged 21 or older who have demonstrated refractive stability for at least 12 months prior, defined by a change in manifest refraction of no more than 0.5 diopters in either sphere or cylinder components.
Is the Technolas 217Z Zyoptix System reusable, and how is it intended to be used in clinical settings?
Yes, the Technolas 217Z Zyoptix System is a reusable device, intended exclusively for use in ophthalmic surgical settings by trained professionals. It performs Laser In-Situ Keratomileusis (LASIK) under the specified refractive correction criteria and patient stability requirements.
What regulatory pathway was followed for FDA approval of this device, and when was the decision made?
The Technolas 217Z Zyoptix System received FDA approval through the Premarket Approval (PMA) pathway under PMA number P990027. The decision to approve was made on February 23, 2000, following a review process that began with the submission received on May 28, 1999.
Are there any specific storage conditions or sterility information provided for the Technolas 217Z Zyoptix System?
The provided data does not include details about sterility or specific storage conditions for the Technolas 217Z Zyoptix System. Users should refer to manufacturer guidelines for proper handling and storage instructions.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P990027 | Class III | Active |
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Manufacturer
- Manufacturer
- Technolas Perfect Vision GmbH
Sources (1)
- FDA PMA P990027 24 fields · synced Sep 18, 2026