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510(k) K020079

BLADEWORKS MICROKERATOME BLADE, MODEL 7061 by Blade Works, Inc. — Product Code HNO

K020079 is an FDA 510(k) premarket notification submitted by Blade Works, Inc. for the device "BLADEWORKS MICROKERATOME BLADE, MODEL 7061". The FDA issued a decision of Substantially Equivalent on April 19, 2002. The device falls under product code HNO (Keratome, Ac-Powered), a Class I device regulated under 21 CFR 886.4370. Blade Works, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2002
Date Received
January 10, 2002
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 Blade Works, Inc.

  • K993225 — BLADEWORKS MICROKERATOME BLADE (March 20, 2000)
  • K993591 — BLADEWORKS DISPOSABLE ALK TUBING (December 28, 1999)

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)
  • 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)

FDA data resources