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510(k) K030891

SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK by Surgistar, Inc. — Product Code HNO

K030891 is an FDA 510(k) premarket notification submitted by Surgistar, Inc. for the device "SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK". The FDA issued a decision of Substantially Equivalent on June 17, 2003. The device falls under product code HNO (Keratome, Ac-Powered), a Class I device regulated under 21 CFR 886.4370. Surgistar, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2003
Date Received
March 21, 2003
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 Surgistar, Inc.

  • K992978 — RICROKERATOME BLADE (November 16, 1999)
  • K941747 — SURGISTAR TROCARS (July 1, 1994)
  • K923689 — SURGISTAR BLADES (September 9, 1992)

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