Clearance Summary
LaserShot M, NaviLase received FDA 510(k) clearance under submission number K192008, sponsored by Vitrolife GmbH. 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 2020-03-25.
- Submission: K192008
- Applicant / Sponsor: Vitrolife GmbH
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6200
- Decision date: 2020-03-25
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.