Identity
- Trade Name
- VISX EXCIMER LASER SYSTEM MODEL C STAR FDA PMA
- Generic Name
- Excimer laser system FDA PMA
Identifiers
- PMA Number
- P990010 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 VISX Star S3 Excimer Laser System is an excimer laser system designed for ophthalmic surgical procedures. It is indicated for performing LASIK on patients 18 years of age or older to reduce or eliminate myopia up to -14.0 diopters, with or without astigmatism ranging from -0.5 to -5.0 diopters.
This system is intended for use in patients who have documented evidence of stable manifest refraction, defined as a change of 0.5 diopters or less per year for at least one year prior to their pre-operative examination. The device has received FDA PMA authorization for its clinical application. Please consult the manufacturer for specific operational and maintenance requirements.
Frequently asked questions
What is the VISX Star S3 Excimer Laser System used for?
The system is indicated for performing LASIK surgery to reduce or eliminate nearsightedness (myopia) and astigmatism in eligible adult patients.
Who is a candidate for treatment with this laser?
Candidates must be at least 18 years old and demonstrate stable vision, defined as a change in manifest refraction of 0.5 diopters or less per year for at least one year prior to the pre-operative exam.
Is this device FDA authorized?
Yes, the VISX Star S3 Excimer Laser System has received FDA PMA (Premarket Approval) authorization for its indicated ophthalmic uses.
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. Sources consulted: visx | visualization components, airbnb/visx: visx | visualization components - GitHub, @visx/visx - npm, visx - A flexible while better integrated with React.js (than D3.js), visx - Visualization Components - Made with React.js
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P990010 | Class III | Active |
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Manufacturer
- Manufacturer
- AMO Manufacturing USA, LLC
Sources (1)
- FDA PMA P990010 24 fields · synced Sep 18, 2026