510(k) K062524
K062524 is an FDA 510(k) premarket notification submitted by Minitube of America, Inc. for the device "OCTAX LASER SHOT SYSTEM". The FDA issued a decision of Substantially Equivalent on December 15, 2006. The device falls under product code MRX (System, Assisted Reproduction Laser), a Class II device regulated under 21 CFR 884.6200. Minitube of America, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 2006
- Date Received
- August 28, 2006
- 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.