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510(k) K192008

LaserShot M, NaviLase by Vitrolife GmbH — Product Code MRX

K192008 is an FDA 510(k) premarket notification submitted by Vitrolife GmbH for the device "LaserShot M, NaviLase". The FDA issued a decision of Substantially Equivalent on March 25, 2020. The device falls under product code MRX (System, Assisted Reproduction Laser), a Class II device regulated under 21 CFR 884.6200. Vitrolife GmbH has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2020
Date Received
July 29, 2019
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 Vitrolife GmbH

  • K213869 — EmbryoSlide+ ic8 dish (March 11, 2022)
  • K182798 — KIDScore D3 (July 19, 2019)
  • K173264 — EmbryoScope+ (May 11, 2018)
  • K150961 — EmbryoSlide Culture Dish (December 4, 2015)
  • K133568 — G-TL (July 16, 2014)
  • K032155 — G-THAWKIT BLAST (May 7, 2004)
  • K032154 — G-FREEZEKIT BLAST (May 7, 2004)
  • K022730 — PERFADEX SOLUTION FOR LUNG PRESERVATION (October 27, 2003)

Other clearances for product code MRX

  • K253333 — Assisted Reproduction Laser System (Model ILS-400M) (June 17, 2026)
  • K202241 — LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) (July 2, 2021)
  • 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)
  • DEN040009 — HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) (November 4, 2004)

FDA data resources