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510(k) K980675

SUMMIT KRUMEICH-BARRAQUER MICROKERATOME by Summit Technology, Inc. — Product Code HNO

K980675 is an FDA 510(k) premarket notification submitted by Summit Technology, Inc. for the device "SUMMIT KRUMEICH-BARRAQUER MICROKERATOME". The FDA issued a decision of Substantially Equivalent on December 22, 1998. The device falls under product code HNO (Keratome, Ac-Powered), a Class I device regulated under 21 CFR 886.4370. Summit Technology, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1998
Date Received
February 20, 1998
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 Summit Technology, Inc.

  • K926470 — LASER AND EMPHASIS SCLEROSTOMY TIP (July 22, 1993)
  • K915651 — OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM (June 15, 1992)
  • K912522 — OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER (July 25, 1991)
  • K904470 — SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE (December 24, 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