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Portable Slit Lamp Microscope

by Suzhou Kangjie Medical, Inc. EUDAMED510(k)

Active European Union and United States

510(k) K162778

Overview

The Portable Slit Lamp Microscope is a biomicroscope designed for ophthalmic examination. It provides high-magnification visualization of the anterior segment of the eye, including the cornea, iris, lens, and anterior chamber, enabling detailed assessment of ocular structures and pathology.

This device is intended for use in clinical ophthalmology settings and is supplied as a portable, AC-powered instrument. It is classified as a Class II medical device under FDA regulations (886.1850) and has received FDA 510(k) clearance and MDR authorization. The device is reusable and requires proper cleaning and maintenance between uses to ensure sterility and functionality.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK162778 Date21 Jul 2017ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited 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 AmericaFranceFranceAustriaHungaryRomaniaUnited 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 AmericaFranceFranceSloveniaBulgariaUnited 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 AmericaPortugalSpainSpainItalyUnited 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 AmericaSpainSpainCroatiaGreeceUnited 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 AmericaMaltaCyprusUnited 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
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
HJO
Device Class
Class II
Regulation
21 CFR Part 886.1850
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What clinical applications is the Portable Slit Lamp Microscope primarily designed for in ophthalmology?

    The Portable Slit Lamp Microscope is specifically designed for examining the anterior segment of the eye, including the cornea, iris, lens, and anterior chamber. This allows clinicians to perform detailed assessments of ocular structures and identify pathologies such as cataracts, corneal abnormalities, or iris irregularities, making it essential for routine eye examinations and diagnostic procedures in clinical ophthalmology.

  • Is this device single-use or reusable, and what maintenance is required to ensure proper functionality?

    The Portable Slit Lamp Microscope is a reusable device. To maintain sterility and functionality between uses, it requires proper cleaning and maintenance as outlined in the manufacturer’s instructions. Regular upkeep is necessary to ensure accurate and safe clinical performance over time.

  • How is the Portable Slit Lamp Microscope powered, and is it designed for portability?

    Yes, the Portable Slit Lamp Microscope is designed with portability in mind and operates using AC power. Its compact and mobile form factor allows it to be easily moved between examination rooms or clinical settings, making it suitable for both stationary and temporary use.

  • What regulatory pathways has the Portable Slit Lamp Microscope undergone, and what does this mean for its use?

    The device has received FDA 510(k) clearance and MDR authorization, confirming it meets regulatory standards for safety and effectiveness. This classification as a Class II medical device under FDA regulations (886.1850) ensures it has undergone rigorous evaluation by regulatory bodies before being approved for clinical use in ophthalmology.