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Optos Limited Panoramic 200CAF

by Optos plc United Kingdom 510(k)

510(k) K100644

Product code MYC

Overview

The Optos Limited Panoramic 200CAF is a scanning laser ophthalmoscope (SLO) used by healthcare professionals in clinical settings to capture wide-field retinal images. It uses red and green lasers to scan the retina in two dimensions via a rotating polygon and motor-driven mirror.

The device is supplied as a Class 2 medical device with product code MYC and is authorized under FDA 510(k) number K100644. It is intended for use in ophthalmic settings and is regulated under 886.1570. The device is not specified as single-use or reusable, and no information regarding MRI safety or storage conditions is provided.

Summary written by AI from registry data, 28 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically 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.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK100644 Date15 Jul 2010ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
MYC
FDA applicant
Optos Plc.
Device Class
Class II
Regulation
21 CFR Part 886.1570
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Optos Panoramic 200CAF used for?

    The Optos Panoramic 200CAF is a scanning laser ophthalmoscope (SLO) used by healthcare professionals in clinical settings to capture wide-field retinal images of the eye.

  • How is the Optos Panoramic 200CAF supplied?

    The device is supplied as a Class 2 medical device with product code MYC and is authorized under FDA 510(k) number K100644 for use in ophthalmic settings.

  • Is the Optos Panoramic 200CAF single-use or reusable?

    The device is not specified as single-use or reusable in the provided information, so clinicians should refer to the manufacturer's instructions for use regarding reprocessing.

  • What are the technical specifications of the Optos Panoramic 200CAF?

    The device uses red and green lasers to scan the retina in two dimensions via a rotating polygon and motor-driven mirror, providing wide-field retinal imaging capabilities.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K100644 24 fields · synced 22 Oct 2026