Clearance Summary
HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS received FDA 510(k) clearance under submission number K120055, sponsored by Hamilton Thorne, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2012-04-24.
- Submission: K120055
- Applicant / Sponsor: Hamilton Thorne, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6200
- Decision date: 2012-04-24
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.