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510(k) K010872

ML BLADE, MODEL ML7030 by Med-Logics, Inc. — Product Code HNO

K010872 is an FDA 510(k) premarket notification submitted by Med-Logics, Inc. for the device "ML BLADE, MODEL ML7030". The FDA issued a decision of Substantially Equivalent on June 22, 2001. The device falls under product code HNO (Keratome, Ac-Powered), a Class I device regulated under 21 CFR 886.4370. Med-Logics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2001
Date Received
March 23, 2001
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 Med-Logics, Inc.

  • K033293 — MED-LOGICS, MODEL ML7090 (January 13, 2004)
  • K022982 — MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB (November 15, 2002)
  • K022716 — MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB (October 11, 2002)
  • K010353 — MED-LOGICS DISPOSABLE ALK TUBING (April 27, 2001)
  • K002515 — MEDLOGICS ML 4000, MODEL 4000 (February 22, 2001)
  • K002279 — ML EYE SPEAR, MODEL ML 27 ES (August 18, 2000)
  • K983448 — ML UNIVERSAL TUBING (December 18, 1998)
  • K981071 — ML MICROKERATOME (July 23, 1998)
  • K972522 — ML-DISPOSABLE PAK (September 30, 1997)
  • K971173 — ML DISPOSABLE ALK TUBING (May 22, 1997)

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