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510(k) K043150

AMADEUS II EPIKERATOME by Sis Ltd., Surgical Instrument Systems — Product Code HNO

K043150 is an FDA 510(k) premarket notification submitted by Sis Ltd., Surgical Instrument Systems for the device "AMADEUS II EPIKERATOME". The FDA issued a decision of Substantially Equivalent on January 31, 2005. The device falls under product code HNO (Keratome, Ac-Powered), a Class I device regulated under 21 CFR 886.4370. Sis Ltd., Surgical Instrument Systems has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2005
Date Received
November 15, 2004
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 Sis Ltd., Surgical Instrument Systems

  • K082871 — XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM (July 9, 2009)
  • K051940 — CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA (September 28, 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)
  • K042083 — MODIFICATION TO VISITOME 20-10 MICROKERATOME (November 16, 2004)
  • K042810 — CENTURION SES EPIKERATOME (October 28, 2004)

FDA data resources