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The MERILAS 810 shortpulse laser is indicated for:

• Photocoagulation
• Iridotomy
• Trabeculoplasty
• Thermotherapy

The MERILAS 532 shortpulse laser is indicated for:

• Photocoagulation
• Iridotomv
• Trabeculoplasty

The MERILAS 577 shortpulse laser is indicated for:

• Photocoagulation
• Iridotomy
• Trabeculoplasty

Not Found

I apologize, but the provided text is an FDA 510(k) clearance letter for three ophthalmic laser devices (Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse). This document does not contain information about acceptance criteria or a study that proves a device meets acceptance criteria, specifically for an Artificial Intelligence (AI) enabled device.

The document primarily focuses on:

• Confirmation of 510(k) clearance: Stating that the devices are substantially equivalent to legally marketed predicate devices.
• Regulatory information: Details about class II classification, compliance requirements, and contact information.
• Indications for Use: Listing the medical conditions each Merilas laser model is intended to treat (photocoagulation, iridotomy, trabeculoplasty, thermotherapy).

Since the request specifically asks for details about acceptance criteria and a study proving an AI device meets them, and the provided text does not contain any such information, I cannot fulfill the request based on this document.

To answer your question, I would need a different type of document, such as a clinical study report, a scientific publication detailing the validation of an AI medical device, or a 510(k) summary specifically for an AI-enabled device that includes performance data.

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