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510(k) K171313

EM-4000 Specular Microscope by Tomey Corporation — Product Code NQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2018
Date Received
May 4, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Specular
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type

Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro.

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Other clearances for product code NQE

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  • K173980 — Specular Microscope CEM-530 (March 14, 2018)
  • K151706 — Specular Microscope CEM- 530 (March 17, 2016)
  • K142417 — SP-1PSpecular Microscope (May 29, 2015)
  • K130565 — SPECULAR MICROSCOPE CEM-530 (November 27, 2013)
  • K120264 — KONAN SPECULAR MICROSCOPE XIV (April 11, 2012)
  • K062763 — NONCON ROBO PACHY F&A (February 22, 2008)
  • K040373 — KERATO ANALYZER (EKA) (March 19, 2004)