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510(k) K014000

VISTITOME 20-10 MICROKERATOME by Biovision AG — Product Code HNO

K014000 is an FDA 510(k) premarket notification submitted by Biovision AG for the device "VISTITOME 20-10 MICROKERATOME". The FDA issued a decision of Substantially Equivalent on March 11, 2002. The device falls under product code HNO (Keratome, Ac-Powered), a Class I device regulated under 21 CFR 886.4370. Biovision AG has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2002
Date Received
December 4, 2001
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 Biovision AG

  • K042083 — MODIFICATION TO VISITOME 20-10 MICROKERATOME (November 16, 2004)
  • K974392 — LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM (January 30, 1998)
  • K926251 — B-SCAN OPTHALMIC ULTRASOUND IMAGING SYSTEM (September 14, 1993)
  • K910027 — CRYSTAL FOCUS EMERALD LASER SLT MCX 1.5 CONVEX PRO (September 25, 1991)
  • K901636 — DIAMOND ND:YAG OPHTHALMIC LASER (June 22, 1990)

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