Star S4 Excimer Laser System with Variable Spot Scanning (VSS) and Wavescan Wavefront System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- VISX EXCIMER LASER SYSTEM MODELS B AND C FDA PMA
- Generic Name
- Excimer laser system FDA PMA
Identifiers
- PMA Number
- P930016 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 Star S4 Excimer Laser System is an ophthalmic device designed for use in laser vision correction procedures. It features Variable Spot Scanning (VSS) technology and the Wavescan Wavefront System to enhance surgical precision.
This system is manufactured by AMO Manufacturing USA, LLC and is supplied as a reusable device. It is authorized under FDA PMA approval and is intended for use in ophthalmic settings. The device includes specific models B and C as referenced in the authorization.
Frequently asked questions
What is the primary function of the Star S4 Excimer Laser System?
The Star S4 Excimer Laser System is designed for ophthalmic procedures, specifically laser vision correction. It utilizes Variable Spot Scanning (VSS) technology and the Wavescan Wavefront System to enhance surgical precision and outcomes in eye treatments.
What are the distinguishing features of this excimer laser system?
The system is distinguished by its Variable Spot Scanning (VSS) capability and the integrated Wavescan Wavefront System. These features allow for customized treatment profiles and improved accuracy during laser vision correction procedures, setting it apart from standard excimer laser systems.
What regulatory approvals does the Star S4 Excimer Laser System have?
The Star S4 Excimer Laser System is authorized under FDA PMA approval with the specific approval for the VISX Excimer Laser System Models B and C. It is classified as a Class III medical device and is manufactured by AMO Manufacturing USA, LLC in Milpitas, California.
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: Premarket Approval (PMA) - FDA, [PDF] PROVEN WAVEFRONT-GUIDED TECHNOLOGY, Refractive Laser Systems and Recent Upgrades - CRST Europe, STAR S4 EXCIMER LASER SYSTEM WITH VARIABLE SPOT ..., Abbott Medical Optics - Visx Star s4 - MedWrench
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P930016 | Class III | Active |
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Manufacturer
- Manufacturer
- AMO Manufacturing USA, LLC
Sources (1)
- FDA PMA P930016 24 fields · synced Sep 18, 2026