Star Excimer Laser System and iDesign Advanced WaveScan Studio
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- VISX MODELB/MODEL C EXCIMER LASER SYSTEM FDA PMA
- Generic Name
- Excimer laser system FDA PMA
Identifiers
- PMA Number
- P910062 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 Excimer Laser System with iDesign Advanced WaveScan Studio is an ophthalmic device used for excimer laser procedures. It is designed to provide precise laser treatment for various eye conditions.
The device is manufactured by AMO Manufacturing USA, LLC in Milpitas, CA and has received FDA PMA approval. It is a Class III device with the product code LZS and is intended for use in ophthalmic settings. The system includes the Model B and Model C configurations.
Frequently asked questions
What is the primary function of the Star Excimer Laser System?
The Star Excimer Laser System with iDesign Advanced WaveScan Studio is designed for ophthalmic procedures, specifically utilizing excimer laser technology for precise eye treatments. It is not described as having specific indications beyond being an excimer laser system for ophthalmic use.
What regulatory approvals does this device have?
The device has received FDA PMA (Pre-Market Approval) with the approval number P910062. It was approved on September 29, 1995, and is classified as a Class III medical device with the product code LZS. The device is also authorized for use in the VISX Model B and Model C configurations.
Who manufactures the Star Excimer Laser System?
The device is manufactured by AMO Manufacturing USA, LLC, located at 510 Cottonwood Dr., Milpitas, CA 95035. The company has multiple FEI numbers associated with this device, indicating various manufacturing facilities or registrations.
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, FDA-2017-M-4022 - Regulations.gov, [PDF] iDESIGN® Refractive Studio - Contentstack, [PDF] PROVEN WAVEFRONT-GUIDED TECHNOLOGY, [PDF] Advanced CustomVue Mixed Astigmatism Patient Information ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P910062 | Class III | Active |
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Manufacturer
- Manufacturer
- AMO Manufacturing USA, LLC
Sources (1)
- FDA PMA P910062 24 fields · synced Sep 18, 2026