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510(k) K193188

MiiS Horus Eye Anterior Camera by Medimaging Integrated Solution, Inc (Miis) — Product Code HJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2020
Date Received
November 18, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type

Other clearances by Medimaging Integrated Solution, Inc (Miis)

  • K253217 — MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet ( (December 23, 2025)
  • K234113 — MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus (May 1, 2024)
  • K223926 — VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box (October 6, 2023)
  • K214050 — ENT Nasopharyngoscope and Accessories (July 1, 2022)
  • K181260 — MiiS Horus Scope DPT 100 (June 21, 2019)
  • K170470 — Digital Eye Anterior Camera (October 6, 2017)

Other clearances for product code HJO

  • K231760 — HP-OCT (HP-OCT) (March 8, 2024)
  • K222372 — Kowa SL-19 (November 21, 2022)
  • K182306 — Sunkingdom Slit Lamp (November 22, 2018)
  • K173771 — IOLMaster 700 (August 24, 2018)
  • K171877 — SLM-1ER, SLM-2ER, SLM-3ER (December 21, 2017)
  • K170470 — Digital Eye Anterior Camera (October 6, 2017)
  • K162778 — Portable Slit Lamp Microscope (July 21, 2017)
  • K162684 — SL 220 (May 31, 2017)
  • K163564 — SLIT LAMP SL-2000 (May 19, 2017)
  • K162636 — Marco Ultra M3, Marco Ultra M4 (April 14, 2017)