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510(k) K162636

Marco Ultra M3, Marco Ultra M4 by Takagi Seiko Co., Ltd. — Product Code HJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2017
Date Received
September 21, 2016
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 Takagi Seiko Co., Ltd.

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  • K172728 — Applanation tonometer AT-1 (October 17, 2017)
  • K152535 — Z5 Slit lamp microscope, Z2 Slit lamp microscope (May 26, 2016)
  • K063352 — ELLEX SLIT LAMP, MODEL 30XL (March 13, 2007)

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  • 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)