Clearance Summary
HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) received FDA 510(k) clearance under submission number DEN040009, sponsored by Hamilton Thorne Biosciences. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2004-11-04.
- Submission: DEN040009
- Applicant / Sponsor: Hamilton Thorne Biosciences
- Clearance pathway: Post-NSE
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6200
- Decision date: 2004-11-04
Classification & Regulation
This clearance is catalogued under FDA product code MRX and 21 CFR 884.6200, within the Obstetrics/Gynecology review panel as a Class II device.