510(k) DEN040009
DEN040009 is an FDA 510(k) premarket notification submitted by Hamilton Thorne Biosciences for the device "HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK)". The FDA issued a decision of De Novo Granted on November 4, 2004. The device falls under product code MRX (System, Assisted Reproduction Laser), a Class II device regulated under 21 CFR 884.6200. Hamilton Thorne Biosciences has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- November 4, 2004
- Date Received
- August 25, 2004
- Clearance Type
- Post-NSE
- 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.