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510(k) K051486

NORWOOD ABBEY CENTURION SES EPIKERATOME by Norwood Abbey , Ltd. — Product Code HNO

K051486 is an FDA 510(k) premarket notification submitted by Norwood Abbey , Ltd. for the device "NORWOOD ABBEY CENTURION SES EPIKERATOME". The FDA issued a decision of Substantially Equivalent on July 6, 2005. The device falls under product code HNO (Keratome, Ac-Powered), a Class I device regulated under 21 CFR 886.4370. Norwood Abbey , Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2005
Date Received
June 6, 2005
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 Norwood Abbey , Ltd.

  • K042810 — CENTURION SES EPIKERATOME (October 28, 2004)
  • K033962 — LAD (EPITURE EASYTOUCH), MODEL LAD-08 (February 20, 2004)
  • K021222 — LAD, MODEL LAD-01 (January 8, 2003)

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)
  • 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