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510(k) K082043

CARRIAZO-PENDULAR MICROKERATOME by Schwind Eye-Tech-Solutions GmbH & Co. KG — Product Code HNO

K082043 is an FDA 510(k) premarket notification submitted by Schwind Eye-Tech-Solutions GmbH & Co. KG for the device "CARRIAZO-PENDULAR MICROKERATOME". The FDA issued a decision of Substantially Equivalent on August 1, 2008. The device falls under product code HNO (Keratome, Ac-Powered), a Class I device regulated under 21 CFR 886.4370. Schwind Eye-Tech-Solutions GmbH & Co. KG has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2008
Date Received
July 18, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Keratome, Ac-Powered
Device Class
Class I
Regulation Number
886.4370
Review Panel
OP
Submission Type

Other clearances by Schwind Eye-Tech-Solutions GmbH & Co. KG

  • K032910 — CARRIAZO PENDULAR (August 30, 2004)

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)
  • 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)
  • K042810 — CENTURION SES EPIKERATOME (October 28, 2004)

FDA data resources