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PANORAMIC200 Ophthalmoscope

by Optos plc United Kingdom 510(k)

510(k) K983999 Product code HLI

Overview

The Panoramic200 Ophthalmoscope is an AC-powered device intended to examine the retina of the eye. It is indicated for diagnosing and monitoring diseases and disorders that manifest in the retina.

This device is classified as a Class 2 medical device under regulation number 886.1570. It has received FDA 510(k) clearance under the reference number K983999.

Summary written by AI from registry data, 26 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 NumberK983999 Date3 Feb 1999ClearedStatusActive

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
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United States — FDA 510(k) Active

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

Specification

510(k) · synced 22 Oct 2026

Full name
PANORAMIC200 Opthalmoscope
510(k) Number
FDA Product Code
HLI
FDA applicant
Optos Plc.
Device Class
Class II
Regulation
21 CFR Part 886.1570
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Other devices from Optos plc

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Questions

  • What is the primary use of the Panoramic200 Ophthalmoscope?

    The Panoramic200 Ophthalmoscope is intended for the examination of the retina. It is specifically indicated for clinicians to diagnose and monitor various diseases and disorders that manifest within the retinal tissue.

  • How is the Panoramic200 Ophthalmoscope powered?

    This device is an AC-powered ophthalmoscope. It requires a connection to an alternating current power source to function, as it is not a battery-operated or portable handheld unit.

  • What is the regulatory status of this device?

    The Panoramic200 Ophthalmoscope has received FDA 510(k) clearance under the reference number K983999. It is classified as a Class 2 medical device under regulation number 886.1570.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K983999 24 fields · synced 22 Oct 2026