510(k) K083208
K083208 is an FDA 510(k) premarket notification submitted by Research Instruments , Ltd. for the device "SATURN ACTIVE LASER SYSTEM". The FDA issued a decision of Substantially Equivalent on August 25, 2009. The device falls under product code MRX (System, Assisted Reproduction Laser), a Class II device regulated under 21 CFR 884.6200. Research Instruments , Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 2009
- Date Received
- October 31, 2008
- 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.