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Rodenstock Scanning Laser Ophthalmoscope

by Rodenstock Instrument Corp.

510(k) K882517

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK882517 Date24 Jan 1989ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HLI
Device Class
Class II
Regulation
21 CFR Part 886.1570
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Rodenstock Scanning Laser Ophthalmoscope is an AC-powered ophthalmoscope designed for the examination of the eye. It utilizes laser technology to provide visualization of ocular structures.

This device is regulated under FDA 510(k) clearance as a Class 2 medical device. It is intended for use by ophthalmic professionals in clinical settings.

Other devices from Rodenstock Instrument Corp.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Rodenstock Scanning Laser Ophthalmoscope?

    This device is an AC-powered ophthalmoscope designed specifically for the examination of the eye. It utilizes laser technology to provide clear visualization of various ocular structures for diagnostic purposes.

  • Who is authorized to use this ophthalmoscope?

    The device is intended for use by ophthalmic professionals. It is designed for operation within clinical settings where specialized eye examinations are performed.

  • What is the regulatory status of this device?

    The Rodenstock Scanning Laser Ophthalmoscope is regulated as a Class 2 medical device and has received FDA 510(k) clearance. This indicates that the device has been found to be substantially equivalent to other legally marketed predicate devices.