System, Assisted Reproduction Laser

Product Code: MRX

Obstetrics/Gynecology In Vitro And Other Medical Laser Products

Definition: 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

Applicable Standards: Laser Products. [1040.10]

Code of Federal Regulations: 884.6200


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as MRX

4032System, Assisted Reproduction LaserAssisted Reproduction Laser System.

Total Product Life Cycle (TPLC) Devices

4032System, Assisted Reproduction LaserAssisted Reproduction Laser System.

Pre-market Notifications for MRX

K202241LYKOS Assisted Reproduction Laser With Dynamic Targeting System (DTS)Hamilton Thorne, Inc.
K192008LaserShot M, NaviLaseVitrolife GmbH
K141434SATURN 5 LASERRESEARCH INSTRUMENTS LTD.
K120055HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOSHAMILTON THORNE, INC.
K083208SATURN ACTIVE LASER SYSTEMRESEARCH INSTRUMENTS LTD.
K063636ZILOS-TKHAMILTON THORNE BIOSCIENCES
K062524OCTAX LASER SHOT SYSTEMMINITUBE OF AMERICA, INC
K060764SATURN 3 LASER SYSTEMRESEARCH INSTRUMENTS LTD.
K050768ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4HAMILTON THORNE BIOSCIENCES

Global Unique Device Identification Database

05060488044915System, assisted reproduction laser
05060488044847System, assisted reproduction laser
05060488044830System, assisted reproduction laser
05060488044823System, assisted reproduction laser
05060488044816System, assisted reproduction laser
05060488043789System, assisted reproduction laser
05060488043772System, assisted reproduction laser
05060488043635System, assisted reproduction laser
05060488043628System, assisted reproduction laser
05060488043406System, assisted reproduction laser
05060488043338System, assisted reproduction laser
05060488043277System, assisted reproduction laser
05060488042812System, assisted reproduction laser
05060488042768System, assisted reproduction laser
05060488042751System, assisted reproduction laser

Maude Adverse Events

LEOPARD IMPLANT 5 DEGREE LORDOTIC 12MMDEPUY SPINE, INC.2006-10-19
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