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510(k) K062465

ZYOPTIX XP EPI SEPARATOR SYSTEM by Bausch & Lomb, Inc. — Product Code HNO

K062465 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "ZYOPTIX XP EPI SEPARATOR SYSTEM". The FDA issued a decision of Substantially Equivalent on September 6, 2006. The device falls under product code HNO (Keratome, Ac-Powered), a Class I device regulated under 21 CFR 886.4370. Bausch & Lomb, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2006
Date Received
August 24, 2006
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 Bausch & Lomb, Inc.

  • K261264 — Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pac (May 15, 2026)
  • K232084 — Stellaris Elite vision enhancement system (February 26, 2024)
  • K192005 — Bausch + Lomb PreVue Inserter for enVista Preloaded (October 4, 2019)
  • K173480 — Crystalsert Lens Delivery System (December 11, 2017)
  • K151102 — Bausch + Lomb Injector System (May 22, 2015)
  • K133486 — STELLARIS PC VISION ENHANCEMENT SYSTEM (March 12, 2014)
  • K133242 — STELLARIS VISION ENHANCEMENT SYSTEM (February 14, 2014)
  • K131958 — BAUSCH & LOMB INJECTOR SYSTEM (January 9, 2014)
  • K133146 — BAUSCH + LUMB, VIS100 INJECTOR SYSTEM (January 3, 2014)
  • K132481 — EASY-LOAD LENS DELIVERY SYSTEM (December 27, 2013)

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)
  • 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