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510(k) K062524

OCTAX LASER SHOT SYSTEM by Minitube of America, Inc. — Product Code MRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2006
Date Received
August 28, 2006
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Assisted Reproduction Laser
Device Class
Class II
Regulation Number
884.6200
Review Panel
OB
Submission Type

This system is inteded to be used to drill a small tangential hole in or to thin the zona pellucida of the embryo in selected in vitro fertilization patients with otherwise poor prognois for successful pregnancy outcome, such as advanced maternal age, prior failed in vitro fertilization procedures, cryopreserved embryos, or abnormal zona pellucida morphology.

Other clearances by Minitube of America, Inc.

  • K050197 — MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045 (October 6, 2006)

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  • K083208 — SATURN ACTIVE LASER SYSTEM (August 25, 2009)
  • K063636 — ZILOS-TK (April 24, 2007)
  • K060764 — SATURN 3 LASER SYSTEM (March 12, 2007)
  • K050768 — ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 (April 28, 2005)
  • DEN040009 — HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) (November 4, 2004)