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510(k) DEN040009

HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) by Hamilton Thorne Biosciences — Product Code MRX

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
November 4, 2004
Date Received
August 25, 2004
Clearance Type
Post-NSE
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 Hamilton Thorne Biosciences

  • K063636 — ZILOS-TK (April 24, 2007)
  • K050768 — ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 (April 28, 2005)

Other clearances for product code MRX

  • K202241 — LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) (July 2, 2021)
  • K192008 — LaserShot M, NaviLase (March 25, 2020)
  • K141434 — SATURN 5 LASER (February 18, 2015)
  • K120055 — HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED (April 24, 2012)
  • K083208 — SATURN ACTIVE LASER SYSTEM (August 25, 2009)
  • K063636 — ZILOS-TK (April 24, 2007)
  • K060764 — SATURN 3 LASER SYSTEM (March 12, 2007)
  • K062524 — OCTAX LASER SHOT SYSTEM (December 15, 2006)
  • K050768 — ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 (April 28, 2005)