Clearance Summary
SATURN ACTIVE LASER SYSTEM received FDA 510(k) clearance under submission number K083208, sponsored by Research Instruments , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2009-08-25.
- Submission: K083208
- Applicant / Sponsor: Research Instruments , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6200
- Decision date: 2009-08-25
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.