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510(k) K031735

CENTURION SES EPIKERATOME by Ciba Vision Corporation — Product Code HNO

K031735 is an FDA 510(k) premarket notification submitted by Ciba Vision Corporation for the device "CENTURION SES EPIKERATOME". The FDA issued a decision of Substantially Equivalent on August 21, 2003. The device falls under product code HNO (Keratome, Ac-Powered), a Class I device regulated under 21 CFR 886.4370. Ciba Vision Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2003
Date Received
June 4, 2003
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 Ciba Vision Corporation

  • K133176 — AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL (January 29, 2014)
  • K123994 — DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PL (February 21, 2013)
  • K113168 — DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTA (March 30, 2012)
  • K083216 — CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES (April 14, 2009)
  • K073459 — CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES (February 28, 2008)
  • K072777 — CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES (January 24, 2008)
  • K062262 — CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIG (November 14, 2006)
  • K041820 — SOLO-CARE AQUA ANTIMICROBIAL LENS CASE (September 9, 2005)
  • K050250 — AQUIFY MULTIPURPOSE SOLUTION (August 10, 2005)
  • K050065 — FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES (May 27, 2005)

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