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510(k) K172994

EPI K Console by Moria SA — Product Code HNO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2017
Date Received
September 27, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratome, Ac-Powered
Device Class
Class I
Regulation Number
886.4370
Review Panel
OP
Submission Type

Other clearances by Moria SA

  • K043183 — EPI-K (March 25, 2005)
  • K032836 — M3 MICROKERATOME (June 18, 2004)
  • K040297 — ONEUSE- PLUS MICROKERATOME (March 31, 2004)
  • K022560 — M2 SINGLE USE MICROKERTOME (September 27, 2002)
  • K003594 — CARRIAZO BARRAQUER SINGLE USE MICROKERATOME (March 9, 2001)
  • K002191 — CARRIAZO BARRAQUER II MICROKERATOME (October 12, 2000)
  • K981742 — ONE UP DISPOSABLE KERATOME HEAD (August 25, 1998)
  • K981741 — CARRIAZO BARRAQUER MICROKERATOME (July 24, 1998)

Other clearances for product code HNO

  • K173371 — VisuMax Femtosecond Laser (April 13, 2018)
  • K072102 — EPIVISION SL SYSTEM (January 16, 2009)
  • K082043 — CARRIAZO-PENDULAR MICROKERATOME (August 1, 2008)
  • K062465 — ZYOPTIX XP EPI SEPARATOR SYSTEM (September 6, 2006)
  • K052891 — HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM (March 23, 2006)
  • K051486 — NORWOOD ABBEY CENTURION SES EPIKERATOME (July 6, 2005)
  • K043183 — EPI-K (March 25, 2005)
  • K043150 — AMADEUS II EPIKERATOME (January 31, 2005)
  • K042083 — MODIFICATION TO VISITOME 20-10 MICROKERATOME (November 16, 2004)
  • K042810 — CENTURION SES EPIKERATOME (October 28, 2004)