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HJO — Biomicroscope, Slit-Lamp, Ac-Powered Class II

FDA Device Classification

Classification Details

Product Code
HJO
Device Class
Class II
Regulation Number
886.1850
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K231760cylite pty.HP-OCT (HP-OCT)March 8, 2024
K222372kowa companyKowa SL-19November 21, 2022
K193188medimaging integrated solution, inc (miis)MiiS Horus Eye Anterior CameraJanuary 14, 2020
K182306chongqing sunkingdom medical instrument coSunkingdom Slit LampNovember 22, 2018
K173771carl zeiss meditecIOLMaster 700August 24, 2018
K171877chongqing kanghua ruiming s and t coSLM-1ER, SLM-2ER, SLM-3ERDecember 21, 2017
K170470medimaging integrated solution, inc (miis)Digital Eye Anterior CameraOctober 6, 2017
K162778suzhou kangjie medicalPortable Slit Lamp MicroscopeJuly 21, 2017
K162684carl zeiss meditecSL 220May 31, 2017
K163564nidek coSLIT LAMP SL-2000May 19, 2017
K162636takagi seiko coMarco Ultra M3, Marco Ultra M4April 14, 2017
K170171carl zeiss meditecIOLMaster 700April 6, 2017
K161607carl zeiss meditecVISULUXFebruary 23, 2017
K161764chongqing yeasn science-technology coSLIT LAMP, Model: YF-100February 16, 2017
K161972topcon corporationSlit Lamp SL-D301December 9, 2016
K160327visia imagingALADDIN HW3.0October 5, 2016
K153545shanghai bolan optical-electric coPortable Slit LampJune 22, 2016
K152535takagi seiko coZ5 Slit lamp microscope, Z2 Slit lamp microscopeMay 26, 2016
K152429shanghai mediworks precision instruments co.Slit Lamp MicroscopeMay 11, 2016
K151394keeler limitedKeeler Slit LampSeptember 10, 2015