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510(k) K972808

HANSATOME MICROKERATOME by Chiron Vision Corp. — Product Code HNO

K972808 is an FDA 510(k) premarket notification submitted by Chiron Vision Corp. for the device "HANSATOME MICROKERATOME". The FDA issued a decision of Substantially Equivalent on October 24, 1997. The device falls under product code HNO (Keratome, Ac-Powered), a Class I device regulated under 21 CFR 886.4370. Chiron Vision Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1997
Date Received
July 28, 1997
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 Chiron Vision Corp.

  • K970727 — MPORT FOLDABLE LENS PLACEMENT SYSTEM (December 17, 1997)
  • K960414 — SYNERGIST POWER PACK (April 24, 1996)
  • K944993 — IOLAB.SITE CD PHACOEMULSIFICATION MODULE (October 12, 1995)
  • K944995 — IOLAB/SITE PERISTALTIC MODULE (October 5, 1995)
  • K951292 — PASSPORT FOLDABLE LENS PLACEMENT SYSTEM (June 2, 1995)
  • K944994 — IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE (March 14, 1995)
  • K941550 — AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT (November 22, 1994)
  • K935233 — IOLAB LACRIMAL DUCT CATHETER (September 15, 1994)
  • K925606 — OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS (August 29, 1994)
  • K926412 — MICRON-SCOPE II (July 19, 1994)

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