Device typeAssisted reproduction laser system: A portable, mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a low-intensity laser beam to ablate the zona pellucida of an embryo during in vitro fertilization (IVF), typically as part of laser-assisted embryo hatching or embryo biopsy. It is intended to be used in conjunction with a compatible inverted-stage light microscope and typically includes a combined laser/microscope objective, a control unit, a camera, and additional supportive devices (e.g., software, foot-switch).
FDA categorySystem, assisted reproduction laser
Device ID05060488042409
Catalog number6-47-500-08
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information