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510(k) K191558

Konan Specular Microscope XVII by Konan Medical, Inc. — Product Code NQE

K191558 is an FDA 510(k) premarket notification submitted by Konan Medical, Inc. for the device "Konan Specular Microscope XVII". The FDA issued a decision of Substantially Equivalent on March 26, 2020. The device falls under product code NQE (Microscope, Specular), a Class II device regulated under 21 CFR 886.1850. Konan Medical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2020
Date Received
June 12, 2019
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.

Other clearances by Konan Medical, Inc.

  • K203244 — CellChek 20 rc (June 15, 2021)
  • K120264 — KONAN SPECULAR MICROSCOPE XIV (April 11, 2012)
  • K081797 — IMAGE STORAGE SYSTEM, MODEL KSS-400 (January 22, 2009)
  • K062763 — NONCON ROBO PACHY F&A (February 22, 2008)
  • K040373 — KERATO ANALYZER (EKA) (March 19, 2004)
  • K950091 — KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000 (March 1, 1995)

Other clearances for product code NQE

  • K173980 — Specular Microscope CEM-530 (March 14, 2018)
  • K171313 — EM-4000 Specular Microscope (January 19, 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)

FDA data resources