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510(k) K052891

HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM by Hawken Industries — Product Code HNO

K052891 is an FDA 510(k) premarket notification submitted by Hawken Industries for the device "HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM". The FDA issued a decision of Substantially Equivalent on March 23, 2006. The device falls under product code HNO (Keratome, Ac-Powered), a Class I device regulated under 21 CFR 886.4370. Hawken Industries has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2006
Date Received
October 13, 2005
Clearance Type
Traditional
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 Hawken Industries

  • K981155 — FLAPMAKER DISPOSABLE MICROKERATOME (August 14, 1998)

Other clearances for product code HNO

  • K173371 — VisuMax Femtosecond Laser (April 13, 2018)
  • K172994 — EPI K Console (October 26, 2017)
  • K072102 — EPIVISION SL SYSTEM (January 16, 2009)
  • K082043 — CARRIAZO-PENDULAR MICROKERATOME (August 1, 2008)
  • K062465 — ZYOPTIX XP EPI SEPARATOR SYSTEM (September 6, 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)

FDA data resources