510(k) K141434

SATURN 5 LASER by Research Instruments , Ltd. — Product Code MRX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 18, 2015
Date Received: May 30, 2014
Clearance Type: Traditional
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 Research Instruments , Ltd.

K133257 — BIOPSY PIPETTES (May 16, 2014)
K112413 — RI MSC (MIGRATION SEDIMENTATION CHAMBER) (July 13, 2012)
K083208 — SATURN ACTIVE LASER SYSTEM (August 25, 2009)
K060764 — SATURN 3 LASER SYSTEM (March 12, 2007)
K003142 — MICROMANIPULATOR (November 22, 2000)
K991261 — ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, AS (August 5, 1999)

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)
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)